<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/NCT02232373</url>
  </required_header>
  <id_info>
    <org_study_id>UoN14048</org_study_id>
    <secondary_id>14GA012</secondary_id>
    <nct_id>NCT02232373</nct_id>
  </id_info>
  <brief_title>Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates</brief_title>
  <acronym>CEDRIC</acronym>
  <official_title>A Pilot Double Blind, Randomised, Placebo Controlled Trial of the Effect of a Diet Low in Poorly Digested Carbohydrates on Symptoms of Post-infective Bowel Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is explore the issues that relate to testing a particular dietary&#xD;
      treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with&#xD;
      which to compare it. In this trial the investigators will look at its effect on symptoms of&#xD;
      people with persistent disturbance in their bowel pattern 3 months after an intestinal&#xD;
      infection with Campylobacter.&#xD;
&#xD;
      The investigators will also look at the changes in gut bacteria that occur with the diet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Failure to recruit&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moderate or substantial improvement in IBS symptoms</measure>
    <time_frame>6 months after star of diet</time_frame>
    <description>The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate control of IBS symptoms</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>Response to a yes/no question &quot;Have your symptoms been adequately controlled?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate control of IBS symptoms</measure>
    <time_frame>6 months after start of diet</time_frame>
    <description>Response to a yes/no question &quot;Have your symptoms been adequately controlled?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of days with loose stool</measure>
    <time_frame>during last 14 days of dietary intervention</time_frame>
    <description>Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in IBSS</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in IBSS</measure>
    <time_frame>6 months after start of diet</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in fasting colonic volume</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fasting colonic gas volume</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in stool concentration of Bifidobacteria</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in stool concentration of Bifidobacteria</measure>
    <time_frame>6 months after start of diet</time_frame>
    <description>This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in EQ-5D-5L score</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>The EQ5D is a validated questionnaire to measure quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in EQ-5D-5L score</measure>
    <time_frame>6 months after start of diet</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in stool concentration of short-chain fatty acids</measure>
    <time_frame>1 month after start of diet</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in stool concentration of short-chain fatty acids</measure>
    <time_frame>6 months after start of diet</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in other clades of stool microbiota</measure>
    <time_frame>1 month after start of diet</time_frame>
    <description>This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in other clades of stool microbiota</measure>
    <time_frame>6 months after start of diet</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Post-infective Bowel Dysfunction</condition>
  <condition>Functional Gastrointestinal Disorders</condition>
  <arm_group>
    <arm_group_label>Normal FODMAP arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low FODMAP arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>low FODMAP dietary advice</intervention_name>
    <description>An education session with a specialist dietitian, and provision of written advice, on how to follow the low FODMAP diet. Second session after one month on re-introduction of FODMAP containing foods.</description>
    <arm_group_label>Low FODMAP arm</arm_group_label>
    <arm_group_label>Normal FODMAP arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Dietary supplementation with maltodextrin 5 grams twice daily for a month</description>
    <arm_group_label>Low FODMAP arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oligofructose</intervention_name>
    <description>Dietary supplementation with oligofructose 5 grams twice daily for a month</description>
    <arm_group_label>Normal FODMAP arm</arm_group_label>
    <other_name>OraftiP95</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participation in the CERAMIC study (see linked protocol)&#xD;
&#xD;
          -  On-going post infective bowel dysfunction (PI-BD) 3 months after confirmation of&#xD;
             Campylobacter spp. in stool sample. This is defined as responding 'No' to the question&#xD;
             &quot;have your bowels returned to normal since your Campylobacter infection?&quot;&#xD;
&#xD;
          -  Will consent to use of data and samples acquired for CERAMIC in the analysis of CEDRIC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        As for CERAMIC study (so already confirmed)&#xD;
&#xD;
          -  Pregnancy declared by the candidate&#xD;
&#xD;
          -  History declared by the candidate of pre-existing gastrointestinal disorder, including&#xD;
             but not limited to: Inflammatory Bowel Disease; Coeliac Disease; Pancreatitis;&#xD;
             Gallstone disease (biliary colic, cholecystitis); Diverticulitis; Cancer of the&#xD;
             gastrointestinal tract; Irritable Bowel Syndrome&#xD;
&#xD;
          -  Reported history of previous resection of any part of the gastrointestinal tract other&#xD;
             than appendix or gallbladder&#xD;
&#xD;
          -  Intestinal stoma&#xD;
&#xD;
          -  Habitual use of opiate analgesics likely to alter bowel function e.g. morphine&#xD;
&#xD;
          -  Use of antibiotics in the preceding four weeks other than for treatment of index&#xD;
             infection. Any condition where the candidate is likely to require a course of&#xD;
             antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent&#xD;
             urinary tract infection, lower limb ulceration&#xD;
&#xD;
          -  Inability to complete the symptom questionnaires e.g. cognitive dysfunction, limiting&#xD;
             memory and understanding&#xD;
&#xD;
          -  Anyone who in the opinion of the investigator is unlikely to be able to comply with&#xD;
             the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse&#xD;
&#xD;
        Addition criteria for CEDRIC study:&#xD;
&#xD;
          -  Use of antibiotics or prescribed probiotics during the CERAMIC study&#xD;
&#xD;
          -  Failure to provide research stool samples during CERAMIC study&#xD;
&#xD;
          -  Dietary practice not compatible with safe implementation of the trial diet&#xD;
             e.g.veganism&#xD;
&#xD;
          -  Medical reasons for pre-existing controlled diet that cannot be safely randomised e.g.&#xD;
             end-stage kidney disease, diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giles AD Major, BM BCh MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robin C Spiller, PhD FRCP</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.nddcbru.org.uk</url>
    <description>Departmental website</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>May 12, 2016</last_update_submitted>
  <last_update_submitted_qc>May 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FODMAPs</keyword>
  <keyword>microbiota</keyword>
  <keyword>oligofructose</keyword>
  <keyword>IBS</keyword>
  <keyword>Irritable bowel syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Intestinal 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>


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/NCT02232373
org study id: UoN14048
secondary id: 14GA012
nct id: NCT02232373
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the study is explore the issues that relate to testing a particular dietary
      treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with
      which to compare it. In this trial the investigators will look at its effect on symptoms of
      people with persistent disturbance in their bowel pattern 3 months after an intestinal
      infection with Campylobacter.

      The investigators will also look at the changes in gut bacteria that occur with the diet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Moderate or substantial improvement in irritable bowel syndrome (IBS) symptoms on IBS-GIS
time frame: 1 month after start of diet
description: The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.
measure: Moderate or substantial improvement in IBS symptoms
time frame: 6 months after star of diet
description: The IBS-GIS (Irritable Bowel Syndrome Global Improvement Score) is a validated 7-point balance scale to assess change in perception of symptoms in functional bowel disorders. Points 6 and 7 on the scale refer to moderate or substantial improvement. The outcome measure will be the proportion of participants in each group marking point 6 or 7 on the balance scale at this time point.
measure: Adequate control of IBS symptoms
time frame: 1 month after start of diet
description: Response to a yes/no question "Have your symptoms been adequately controlled?"
measure: Adequate control of IBS symptoms
time frame: 6 months after start of diet
description: Response to a yes/no question "Have your symptoms been adequately controlled?"
measure: Percentage of days with loose stool
time frame: during last 14 days of dietary intervention
description: Percentage of days with at least one stool of consistency type 6 or 7 on the Bristol stool form scale
measure: Change from baseline in IBSS
time frame: 1 month after start of diet
description: The IBSS (Irritable Bowel Symptom Severity Scale) is a validated composite score of symptoms in functional intestinal disorders
measure: Change from baseline in IBSS
time frame: 6 months after start of diet
measure: Change from baseline in fasting colonic volume
time frame: 1 month after start of diet
description: This is a mechanistic endpoint. Colonic volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.
measure: Change in fasting colonic gas volume
time frame: 1 month after start of diet
description: This is a mechanistic endpoint. Colonic gas volume will be assessed by Magnetic Resonance Imaging at baseline and after intervention.
measure: Change from baseline in stool concentration of Bifidobacteria
time frame: 1 month after start of diet
description: This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
measure: Change from baseline in stool concentration of Bifidobacteria
time frame: 6 months after start of diet
description: This is a mechanistic endpoint, to assess changes in the microbiota caused by dietary intervention
measure: Change from baseline in EQ-5D-5L score
time frame: 1 month after start of diet
description: The EQ5D is a validated questionnaire to measure quality of life
measure: Change from baseline in EQ-5D-5L score
time frame: 6 months after start of diet
measure: Change from baseline in stool concentration of short-chain fatty acids
time frame: 1 month after start of diet
measure: Change from baseline in stool concentration of short-chain fatty acids
time frame: 6 months after start of diet
measure: Change from baseline in other clades of stool microbiota
time frame: 1 month after start of diet
description: This will be exploratory work to assess the effect of the diet on other constituents of the stool microbiota
measure: Change from baseline in other clades of stool microbiota
time frame: 6 months after start of diet
arm group label: Normal FODMAP arm
arm group type: Sham Comparator
description: Low FODMAP dietary advice; participants to supplement diet with oligofructose, a poorly digested carbohydrate that will restore FODMAP content to the diet.
arm group label: Low FODMAP arm
arm group type: Experimental
description: Low FODMAP dietary advice; participants to supplement with maltodextrin (easily digestible carbohydrate)
intervention type: Behavioral
intervention name: low FODMAP dietary advice
description: An education session with a specialist dietitian, and provision of written advice, on how to follow the low FODMAP diet. Second session after one month on re-introduction of FODMAP containing foods.
arm group label: Low FODMAP arm
arm group label: Normal FODMAP arm
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: Dietary supplementation with maltodextrin 5 grams twice daily for a month
arm group label: Low FODMAP arm
intervention type: Dietary Supplement
intervention name: Oligofructose
description: Dietary supplementation with oligofructose 5 grams twice daily for a month
arm group label: Normal FODMAP arm
other name: OraftiP95
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giles AD Major, BM BCh MRCP
role: Principal Investigator
affiliation: University of Nottingham
last name: Robin C Spiller, PhD FRCP
role: Study Chair
affiliation: University of Nottingham
facility: 
country: United Kingdom
url: http://www.nddcbru.org.uk
description: Departmental website
responsible party type: Sponsor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Intestinal Diseases
sharing ipd: No