<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/NCT02977975</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1130/REK</org_study_id>
    <nct_id>NCT02977975</nct_id>
  </id_info>
  <brief_title>Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome</brief_title>
  <official_title>A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut&#xD;
      in the treatment of irritable bowel syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects&#xD;
      around 11% of the population globally. Several factors have been implicated in the&#xD;
      pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet .&#xD;
      More recently, it has become clear that the gastrointestinal microbiota may play a critical&#xD;
      role in the pathophysiology of this functional GI condition.&#xD;
&#xD;
      Several studies have shown that an altered gut microbiota profile is present in at least some&#xD;
      subgroups of IBS patients. This may, in part, explain why a proportion of IBS patients have&#xD;
      elevated levels of inflammatory mediators in systemic circulation.&#xD;
&#xD;
      Gut microbiome manipulation, for example through the use of probiotic and prebiotic&#xD;
      supplements, has shown some promise in the treatment of IBS. However, the research in this&#xD;
      area is still in its infancy, and it remains unclear what type of intervention that is the&#xD;
      preferred choice in cases of IBS.&#xD;
&#xD;
      Several studies have investigated how the use of probiotic supplements containing&#xD;
      Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to&#xD;
      date, no studies have assessed whether fermented vegetables, a &quot;natural&quot; source of probiotic&#xD;
      bacteria such as Lactobacillus plantarum, are useful in the treatment of IBS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>IBS Symptom Severity Scale (IBS-SSS).</measure>
    <time_frame>Change from day 0 to day 42</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Change from day 0 to day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal microbiome diversity</measure>
    <time_frame>Change from day 0 to day 42</time_frame>
    <description>16S rRNA gene sequences (prokaryotes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Quality of Life Scale (QOLS)</measure>
    <time_frame>Change from day 0 to day 42</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Raw sauerkraut</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pasteurized sauerkraut</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>75 grams of pasteurized sauerkraut, each day for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Raw sauerkraut</intervention_name>
    <description>Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.</description>
    <arm_group_label>Raw sauerkraut</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pasteurized sauerkraut</intervention_name>
    <description>Sauerkraut without live bacteria.</description>
    <arm_group_label>Pasteurized sauerkraut</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3&#xD;
        months prior to diagnosis):&#xD;
&#xD;
        Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months&#xD;
        associated with two or more of the following:&#xD;
&#xD;
          1. Improvement with defecation&#xD;
&#xD;
          2. Onset associated with a change in frequency of stool&#xD;
&#xD;
          3. Onset associated with a change in form (appearance) of stool&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Metabolic disease&#xD;
&#xD;
          -  Chronic infection&#xD;
&#xD;
          -  Organic gastrointestinal disorder&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Volvat Medisinske Senter, Majorstuen</name>
      <address>
        <city>Oslo</city>
        <zip>0370</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Eirik Garnås</investigator_full_name>
    <investigator_title>Public Health Nutritionist</investigator_title>
  </responsible_party>
  <keyword>Irritable bowel syndrome</keyword>
  <keyword>The human microbiome</keyword>
  <keyword>Microbiota</keyword>
  <keyword>Gut microbiota</keyword>
  <keyword>Probiotics</keyword>
  <keyword>Sauerkraut</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT02977975
org study id: 2016/1130/REK
nct id: NCT02977975
lead sponsor: 
has dmc: No
The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut
      in the treatment of irritable bowel syndrome.
Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects
      around 11% of the population globally. Several factors have been implicated in the
      pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet .
      More recently, it has become clear that the gastrointestinal microbiota may play a critical
      role in the pathophysiology of this functional GI condition.

      Several studies have shown that an altered gut microbiota profile is present in at least some
      subgroups of IBS patients. This may, in part, explain why a proportion of IBS patients have
      elevated levels of inflammatory mediators in systemic circulation.

      Gut microbiome manipulation, for example through the use of probiotic and prebiotic
      supplements, has shown some promise in the treatment of IBS. However, the research in this
      area is still in its infancy, and it remains unclear what type of intervention that is the
      preferred choice in cases of IBS.

      Several studies have investigated how the use of probiotic supplements containing
      Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to
      date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic
      bacteria such as Lactobacillus plantarum, are useful in the treatment of IBS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: IBS Symptom Severity Scale (IBS-SSS).
time frame: Change from day 0 to day 42
measure: Body weight
time frame: Change from day 0 to day 42
measure: Fecal microbiome diversity
time frame: Change from day 0 to day 42
description: 16S rRNA gene sequences (prokaryotes)
measure: The Quality of Life Scale (QOLS)
time frame: Change from day 0 to day 42
arm group label: Raw sauerkraut
arm group type: Experimental
description: 75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
arm group label: Pasteurized sauerkraut
arm group type: Other
description: 75 grams of pasteurized sauerkraut, each day for 6 weeks.
intervention type: Other
intervention name: Raw sauerkraut
description: Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.
arm group label: Raw sauerkraut
intervention type: Other
intervention name: Pasteurized sauerkraut
description: Sauerkraut without live bacteria.
arm group label: Pasteurized sauerkraut
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Eirik Garnås
investigator title: Public Health Nutritionist
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome