xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016322</url>
    </required_header>
    <id_info>
      <org_study_id>NL85061.042.23</org_study_id>
      <secondary_id>KIEM.K23.01.148</secondary_id>
      <nct_id>NCT06016322</nct_id>
    </id_info>
    <brief_title>Chicory Fiber in IBD</brief_title>
    <acronym>Chic-IBD</acronym>
    <official_title>The Effect of Dried Chicory Root on Inflammation, Gut Microbiota and Complaints in Patients With Inflammatory Bowel Disease: a Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Center Groningen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>WholeFiber</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>MyMicroZoo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Medical Center Groningen</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical pilot trial is to test the use of chicory fibre in patients with&#xD;
        IBD.The main questions it aims to answer are:&#xD;
  &#xD;
        what the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin,&#xD;
        IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in&#xD;
        patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of&#xD;
        10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g&#xD;
        WholeFiberTM per day for the last two weeks (equals 17 g fiber).&#xD;
  &#xD;
        Researchers will compare the above mentioned outcomes before and after the intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: Inflammatory Bowel Diseases (IBD), of which Ulcerative Colitis (UC) and Crohn's&#xD;
        Disease (CD) are the main types, includes recurring episodes of inflammation in the&#xD;
        gastro-intestinal tract and severely impacts quality of life (QoL), leads to more&#xD;
        hospitalization and increases the mortality risk. An impaired gut microbiota and lower levels&#xD;
        of short-chain fatty acids (SCFA) have been linked to the pathophysiology. A higher fiber&#xD;
        intake is linked to positive changes in the gut microbiota and increase SCFA-production,&#xD;
        however patients with IBD consume too little dietary fiber. WholeFiberTM, a dried vegetable&#xD;
        rich in 4 types of prebiotic fiber, may be an easy solution to increase dietary fiber intake,&#xD;
        impact the gut microbiota and SCFA, IBD-complaints and health parameters.&#xD;
  &#xD;
        Objective: To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal&#xD;
        calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA&#xD;
        levels in patients with CD and UC.&#xD;
  &#xD;
        Study design: this is a 4-week pilot study with one arm to explore the effects of a&#xD;
        WholeFiberTM intervention. Measurements will take place before and after the intervention,&#xD;
        questionnaires will also be conducted halfway.&#xD;
  &#xD;
        Study population: in total 12 patients with mild to moderate IBD complaints will be included,&#xD;
        of which 6 UC and 6 CD patients, to investigate if there is a difference between the two&#xD;
        groups in efficacy of WholeFiberTM.&#xD;
  &#xD;
        Intervention: Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks&#xD;
        (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks&#xD;
        (equals 17 g fiber).&#xD;
  &#xD;
        Main study parameters/endpoints: the primary parameter is change in fecal calprotectin after&#xD;
        the 4-week intervention, which is a marker for inflammation in the gut. Secondary parameters&#xD;
        are improvements in IBD-complaints, QoL, serum markers, and changes in the gut microbiota and&#xD;
        increase in fecal SCFA-production. Moreover, it will be explored whether the response on the&#xD;
        intervention will be different between UC and CD. Furthermore, an evaluation questionnaire&#xD;
        will be conducted to assess feasibility and acceptance of the WholeFiberTM intervention in&#xD;
        this population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Pilot study investigating the effect of additional dietary intake 10-20 gram of a dried vegetable fibre. The difference in outcomes before and after the intervention in fecal calprotectin, IBD complaints, QOL, serum inflammatory markers, gut microbiota and SCFA will be determined</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in fecal calprotectin</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels in patients with CD and UC.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in IBD complaints by HBI for CD</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on IBD-complaints in patients with CD measured by the Harvey Bradshaw Index (HBI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in IBD complaints by SCCAI for UC</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on IBD-complaints in patients UC measured by the Simple Clinical Colitis Activity Index (SCCAI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in QOL measured by IBDQ</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on QoL measured by the IBDQ (Irvine 1999)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Food-related Quality of Life (FrQOL)</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Food-related QoL measured by a validated instrument by Hughes et al 2015</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in stool consistency</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on stool consistency. Stool consistency will be measured using the validated Bristol Stool Chart.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in stool frequency</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on stool frequency. Patients will be asked how often they defecated per day during the past week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal microbiota composition: Shannon-index</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal microbiota composition. Next generation sequencing will be used ot determine bacterial richness (Shannon-index)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal microbiota composition by beta-diversity</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal microbiota composition. Next generation sequencing will be used ot determine bacterial interindividual variations (beta-diversity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal SCFA levels: lactate</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on fecal lactate in patients with CD and UC measured by a conductivity detector.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal SCFA levels: formate</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on fecal formate in patients with CD and UC measured by a conductivity detector.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal SCFA levels; butyrate</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on fecal butyrate in patients with CD and UC measured by a conductivity detector.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal SCFA levels: propionate</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on fecal propionate in patients with CD and UC measured by a conductivity detector.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal SCFA levels: acetate</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention on fecal acetate in patients with CD and UC measured by a conductivity detector.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal acidity (pH)</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal acidity (pH) by a PCE-228-R pH and redox meter in a stool sample.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fecal redox status</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal redox status, measured by PCE-228-R instrument.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum leukocytes</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on leukocytes count.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum thrombocytes</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on thrombocytes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum iron status: serum iron</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC serum iron [micromol/L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum iron status: Total Iron Binding Capacity (TIBC)</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Total Iron Binding Capacity (TIBC) [micromol/L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum iron status: ferritin</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on ferritin [microg/L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum iron status: transferrin</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on transferrin [g/L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum ALAT</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Alanine Aminotransferase (ALAT).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum ASAT</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Aspartate Aminotransferase (ALAT).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum GGT</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Gamma-Glutamyl Transferase (GGT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum creatinine</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on iron status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in C-reactive protein (CRP)</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on C-reactive protein (CRP), which is an inflammation marker.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker IL-6 analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-6 on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker IL-8 analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-8 on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker IL-10 analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-10 on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory markers IL-12 analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-12 on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory markerIL-17a analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-17a on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker IL-22 analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-22 on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker IL-23 analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-23 on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker TNF-alpha analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker TNF-alpha on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammatory marker Interferon(IFN)-gamma analysed by an ELISA kit</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker Interferon(IFN)-gamma on an ELISA kit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in oxidative stress measured by free thiols</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on oxidative stress measured by free thiols.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Difference in change in fecal calprotectin between patients with CD and UC</measure>
      <time_frame>difference between baseline and after 4-week intervention</time_frame>
      <description>To explore the difference between CD an UC in change in the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels</description>
    </other_outcome>
    <other_outcome>
      <measure>Appreciation of WholeFiberTM evaluated by patients with CD and UC?</measure>
      <time_frame>after 4-week intervention</time_frame>
      <description>How participants with CD and UC appreciated of WholeFiberTM by chosing a digit on a vascale from 1 to 10, being 1 the lowest number of appreciation and 10 the highest number</description>
    </other_outcome>
    <other_outcome>
      <measure>The convenience of the use of WholeFiberTM evaluated by patients with CD and UC?</measure>
      <time_frame>after 4-week intervention</time_frame>
      <description>Participants are asked to rate the following statement &quot;I find Whole Fiber easy to use&quot; and can answer on a Lickert with 5 different categories: 1. completely disagree 2. disagree 3. neutral, 4 agree 5. completely agree.</description>
    </other_outcome>
    <other_outcome>
      <measure>The palatability of the use of WholeFiberTM evaluated by patients with CD and UC?</measure>
      <time_frame>after 4-week intervention</time_frame>
      <description>Participants are asked to rate the following statement &quot;I find Whole Fiber tasty to eat&quot; and can answer on a Lickert with 5 different categories: 1. completely disagree 2. disagree 3. neutral, 4 agree 5. completely agree.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <condition>Dietary Exposure</condition>
    <arm_group>
      <arm_group_label>Before and after study in 6 patients with UC and 6 patients wiht CD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a 4-week before-after pilot study to explore the effectiveness of a WholeFiber Trademark (TM) intervention (a dried vegetable rich in prebiotic intrinsic fibers) on inflammation, fecal gut microbiota and metabolites, IBD-complaints and QoL and assesses its feasibility. In this before-after study, 12 patients with IBD will receive WholeFiberTM; of which 6 patients with CD and 6 patients with UC to assess if there is a difference in effect between these groups of patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Chicory Fiber</intervention_name>
      <description>Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber).&#xD;
  WholeFiberTM is a fiber-rich dried vegetable made from the chicory root that contains four types of prebiotic fibers (inulin, pectin, cellulose, hemi-cellulose).</description>
      <arm_group_label>Before and after study in 6 patients with UC and 6 patients wiht CD</arm_group_label>
      <other_name>WholeFiber Trademark (TM)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women aged ≥18 years;&#xD;
  &#xD;
            -  Having a diagnosis of IBD (either UC or CD) and undergoing treatment at the policlinic&#xD;
               at the University Medical Center Groningen;&#xD;
  &#xD;
            -  Mild or moderate IBD, defined as fecal calprotectin levels ≥100 μg and Harvey Bradshaw&#xD;
               Index (HBI) &lt;8 for CD patients or Simple Clinical Colitis Activity Index (SCCAI) &lt;5&#xD;
               for UC patients;&#xD;
  &#xD;
            -  Using stable maintenance therapy for at least 12 weeks;&#xD;
  &#xD;
            -  Being able to read and speak Dutch;&#xD;
  &#xD;
            -  Willing to come to the University Medical Center Groningen for practical reasons&#xD;
               (visiting the study site);&#xD;
  &#xD;
            -  Willing to continue their regular lifestyle patterns during the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a medical history that may impact study outcomes, such as a diagnosis of&#xD;
               diabetes mellitus type 2, heart disease, renal disease, cancer, celiac disease;&#xD;
  &#xD;
            -  Having an ileostomy or colostomy, as this greatly impacts bowel function and gut&#xD;
               microbiota composition;&#xD;
  &#xD;
            -  Having a clinically significant stenosis;&#xD;
  &#xD;
            -  Use of antibiotics &lt;4 weeks before study start;&#xD;
  &#xD;
            -  Use of prebiotics, probiotics and/or synbiotic (this should be stopped 4 weeks before&#xD;
               start of the study) or other fiber supplements such as psyllium;&#xD;
  &#xD;
            -  Use of tube feeding or sib-feeding;&#xD;
  &#xD;
            -  Being pregnant or lactating;&#xD;
  &#xD;
            -  Participation in another clinical study at the same time;&#xD;
  &#xD;
            -  Unable or unwilling to comply to study rules&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University Medical Center Groningen</name>
        <address>
          <city>Groningen</city>
          <zip>9713GZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <link>
      <url>https://www.cambridge.org/core/journals/gut-microbiome/article/dried-chicory-root-improves-bowel-function-benefits-intestinal-microbial-trophic-chains-and-increases-faecal-and-circulating-short-chain-fatty-acids-in-subjects-at-risk-for-type-2-diabetes/6209AEAFBDDB181197F22AE24388186B</url>
      <description>Dried Chicory Root Improves Bowel Function, Benefits Intestinal Microbial Trophic Chains and Increases Faecal and Circulating Short Chain Fatty Acids in Subjects at Risk for Type 2 Diabetes</description>
    </link>
    <results_reference>
      <citation>Puhlmann ML, de Vos WM. Back to the Roots: Revisiting the Use of the Fiber-Rich Cichorium intybusL. Taproots. Adv Nutr. 2020 Jul 1;11(4):878-889. doi: 10.1093/advances/nmaa025. Erratum In: Adv Nutr. 2021 Jul 30;12(4):1598.</citation>
      <PMID>32199025</PMID>
    </results_reference>
    <results_reference>
      <citation>Peters V, Dijkstra G, Campmans-Kuijpers MJE. Are all dietary fibers equal for patients with inflammatory bowel disease? A systematic review of randomized controlled trials. Nutr Rev. 2022 Apr 8;80(5):1179-1193. doi: 10.1093/nutrit/nuab062.</citation>
      <PMID>34486663</PMID>
    </results_reference>
    <results_reference>
      <citation>Puhlmann ML, de Vos WM. Intrinsic dietary fibers and the gut microbiome: Rediscovering the benefits of the plant cell matrix for human health. Front Immunol. 2022 Aug 18;13:954845. doi: 10.3389/fimmu.2022.954845. eCollection 2022.</citation>
      <PMID>36059540</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Inflammatory bowel disease</keyword>
    <keyword>dietary fiber</keyword>
    <keyword>gut microbiome</keyword>
    <keyword>inflammation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016322
  org study id: NL85061.042.23
  secondary id: KIEM.K23.01.148
  nct id: NCT06016322
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical pilot trial is to test the use of chicory fibre in patients with
        IBD.The main questions it aims to answer are:
  
        what the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin,
        IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA levels in
        patients with Crohn's disease and ulcerative colitis Participants will receive 1 sachet of
        10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g
        WholeFiberTM per day for the last two weeks (equals 17 g fiber).
  
        Researchers will compare the above mentioned outcomes before and after the intervention.
  Rationale: Inflammatory Bowel Diseases (IBD), of which Ulcerative Colitis (UC) and Crohn's
        Disease (CD) are the main types, includes recurring episodes of inflammation in the
        gastro-intestinal tract and severely impacts quality of life (QoL), leads to more
        hospitalization and increases the mortality risk. An impaired gut microbiota and lower levels
        of short-chain fatty acids (SCFA) have been linked to the pathophysiology. A higher fiber
        intake is linked to positive changes in the gut microbiota and increase SCFA-production,
        however patients with IBD consume too little dietary fiber. WholeFiberTM, a dried vegetable
        rich in 4 types of prebiotic fiber, may be an easy solution to increase dietary fiber intake,
        impact the gut microbiota and SCFA, IBD-complaints and health parameters.
  
        Objective: To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal
        calprotectin, IBD-complaints and QoL, serum inflammatory markers, gut microbiota and SCFA
        levels in patients with CD and UC.
  
        Study design: this is a 4-week pilot study with one arm to explore the effects of a
        WholeFiberTM intervention. Measurements will take place before and after the intervention,
        questionnaires will also be conducted halfway.
  
        Study population: in total 12 patients with mild to moderate IBD complaints will be included,
        of which 6 UC and 6 CD patients, to investigate if there is a difference between the two
        groups in efficacy of WholeFiberTM.
  
        Intervention: Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks
        (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks
        (equals 17 g fiber).
  
        Main study parameters/endpoints: the primary parameter is change in fecal calprotectin after
        the 4-week intervention, which is a marker for inflammation in the gut. Secondary parameters
        are improvements in IBD-complaints, QoL, serum markers, and changes in the gut microbiota and
        increase in fecal SCFA-production. Moreover, it will be explored whether the response on the
        intervention will be different between UC and CD. Furthermore, an evaluation questionnaire
        will be conducted to assess feasibility and acceptance of the WholeFiberTM intervention in
        this population.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Pilot study investigating the effect of additional dietary intake 10-20 gram of a dried vegetable fibre. The difference in outcomes before and after the intervention in fecal calprotectin, IBD complaints, QOL, serum inflammatory markers, gut microbiota and SCFA will be determined
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: change in fecal calprotectin
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels in patients with CD and UC.
  measure: Change in IBD complaints by HBI for CD
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on IBD-complaints in patients with CD measured by the Harvey Bradshaw Index (HBI)
  measure: Change in IBD complaints by SCCAI for UC
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on IBD-complaints in patients UC measured by the Simple Clinical Colitis Activity Index (SCCAI)
  measure: Change in QOL measured by IBDQ
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on QoL measured by the IBDQ (Irvine 1999)
  measure: Change in the Food-related Quality of Life (FrQOL)
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Food-related QoL measured by a validated instrument by Hughes et al 2015
  measure: Change in stool consistency
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on stool consistency. Stool consistency will be measured using the validated Bristol Stool Chart.
  measure: Change in stool frequency
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on stool frequency. Patients will be asked how often they defecated per day during the past week
  measure: Change in fecal microbiota composition: Shannon-index
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal microbiota composition. Next generation sequencing will be used ot determine bacterial richness (Shannon-index)
  measure: Change in fecal microbiota composition by beta-diversity
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal microbiota composition. Next generation sequencing will be used ot determine bacterial interindividual variations (beta-diversity)
  measure: Change in fecal SCFA levels: lactate
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on fecal lactate in patients with CD and UC measured by a conductivity detector.
  measure: Change in fecal SCFA levels: formate
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on fecal formate in patients with CD and UC measured by a conductivity detector.
  measure: Change in fecal SCFA levels; butyrate
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on fecal butyrate in patients with CD and UC measured by a conductivity detector.
  measure: Change in fecal SCFA levels: propionate
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on fecal propionate in patients with CD and UC measured by a conductivity detector.
  measure: Change in fecal SCFA levels: acetate
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention on fecal acetate in patients with CD and UC measured by a conductivity detector.
  measure: Change in fecal acidity (pH)
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal acidity (pH) by a PCE-228-R pH and redox meter in a stool sample.
  measure: Change in fecal redox status
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on fecal redox status, measured by PCE-228-R instrument.
  measure: Change in serum leukocytes
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on leukocytes count.
  measure: Change in serum thrombocytes
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on thrombocytes.
  measure: Change in serum iron status: serum iron
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC serum iron [micromol/L]
  measure: Change in serum iron status: Total Iron Binding Capacity (TIBC)
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Total Iron Binding Capacity (TIBC) [micromol/L]
  measure: Change in serum iron status: ferritin
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on ferritin [microg/L]
  measure: Change in serum iron status: transferrin
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on transferrin [g/L]
  measure: Change in serum ALAT
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Alanine Aminotransferase (ALAT).
  measure: Change in serum ASAT
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Aspartate Aminotransferase (ALAT).
  measure: Change in serum GGT
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on Gamma-Glutamyl Transferase (GGT)
  measure: Change in serum creatinine
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on iron status.
  measure: Change in C-reactive protein (CRP)
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on C-reactive protein (CRP), which is an inflammation marker.
  measure: Change in inflammatory marker IL-6 analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-6 on an ELISA kit
  measure: Change in inflammatory marker IL-8 analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-8 on an ELISA kit
  measure: Change in inflammatory marker IL-10 analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-10 on an ELISA kit
  measure: Change in inflammatory markers IL-12 analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-12 on an ELISA kit
  measure: Change in inflammatory markerIL-17a analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-17a on an ELISA kit
  measure: Change in inflammatory marker IL-22 analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-22 on an ELISA kit
  measure: Change in inflammatory marker IL-23 analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker IL-23 on an ELISA kit
  measure: Change in inflammatory marker TNF-alpha analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker TNF-alpha on an ELISA kit
  measure: Change in inflammatory marker Interferon(IFN)-gamma analysed by an ELISA kit
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on the inflammatory marker Interferon(IFN)-gamma on an ELISA kit
  measure: Change in oxidative stress measured by free thiols
  time frame: difference between baseline and after 4-week intervention
  description: To explore the effect of a 4-week WholeFiberTM intervention in patients with CD and UC on oxidative stress measured by free thiols.
  measure: Difference in change in fecal calprotectin between patients with CD and UC
  time frame: difference between baseline and after 4-week intervention
  description: To explore the difference between CD an UC in change in the effect of a 4-week 10-20 g/day WholeFiberTM intervention on fecal calprotectin levels
  measure: Appreciation of WholeFiberTM evaluated by patients with CD and UC?
  time frame: after 4-week intervention
  description: How participants with CD and UC appreciated of WholeFiberTM by chosing a digit on a vascale from 1 to 10, being 1 the lowest number of appreciation and 10 the highest number
  measure: The convenience of the use of WholeFiberTM evaluated by patients with CD and UC?
  time frame: after 4-week intervention
  description: Participants are asked to rate the following statement "I find Whole Fiber easy to use" and can answer on a Lickert with 5 different categories: 1. completely disagree 2. disagree 3. neutral, 4 agree 5. completely agree.
  measure: The palatability of the use of WholeFiberTM evaluated by patients with CD and UC?
  time frame: after 4-week intervention
  description: Participants are asked to rate the following statement "I find Whole Fiber tasty to eat" and can answer on a Lickert with 5 different categories: 1. completely disagree 2. disagree 3. neutral, 4 agree 5. completely agree.
  arm group label: Before and after study in 6 patients with UC and 6 patients wiht CD
  arm group type: Experimental
  description: This is a 4-week before-after pilot study to explore the effectiveness of a WholeFiber Trademark (TM) intervention (a dried vegetable rich in prebiotic intrinsic fibers) on inflammation, fecal gut microbiota and metabolites, IBD-complaints and QoL and assesses its feasibility. In this before-after study, 12 patients with IBD will receive WholeFiberTM; of which 6 patients with CD and 6 patients with UC to assess if there is a difference in effect between these groups of patients.
  intervention type: Dietary Supplement
  intervention name: Chicory Fiber
  description: Subjects will receive 1 sachet of 10g WholeFiberTM for the first 2 weeks (equals 8.5 g fiber), and 2 sachets of 10g WholeFiberTM per day for the last two weeks (equals 17 g fiber).
  WholeFiberTM is a fiber-rich dried vegetable made from the chicory root that contains four types of prebiotic fibers (inulin, pectin, cellulose, hemi-cellulose).
  arm group label: Before and after study in 6 patients with UC and 6 patients wiht CD
  other name: WholeFiber Trademark (TM)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Netherlands
  url: https://www.cambridge.org/core/journals/gut-microbiome/article/dried-chicory-root-improves-bowel-function-benefits-intestinal-microbial-trophic-chains-and-increases-faecal-and-circulating-short-chain-fatty-acids-in-subjects-at-risk-for-type-2-diabetes/6209AEAFBDDB181197F22AE24388186B
  description: Dried Chicory Root Improves Bowel Function, Benefits Intestinal Microbial Trophic Chains and Increases Faecal and Circulating Short Chain Fatty Acids in Subjects at Risk for Type 2 Diabetes
  citation: Puhlmann ML, de Vos WM. Back to the Roots: Revisiting the Use of the Fiber-Rich Cichorium intybusL. Taproots. Adv Nutr. 2020 Jul 1;11(4):878-889. doi: 10.1093/advances/nmaa025. Erratum In: Adv Nutr. 2021 Jul 30;12(4):1598.
  PMID: 32199025
  citation: Peters V, Dijkstra G, Campmans-Kuijpers MJE. Are all dietary fibers equal for patients with inflammatory bowel disease? A systematic review of randomized controlled trials. Nutr Rev. 2022 Apr 8;80(5):1179-1193. doi: 10.1093/nutrit/nuab062.
  PMID: 34486663
  citation: Puhlmann ML, de Vos WM. Intrinsic dietary fibers and the gut microbiome: Rediscovering the benefits of the plant cell matrix for human health. Front Immunol. 2022 Aug 18;13:954845. doi: 10.3389/fimmu.2022.954845. eCollection 2022.
  PMID: 36059540
  responsible party type: Sponsor
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  sharing ipd: No