<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/NCT02210572</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)296/2013/A-4/2014</org_study_id>
    <nct_id>NCT02210572</nct_id>
  </id_info>
  <brief_title>Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms</brief_title>
  <official_title>Effect of Prebiotics on Intestinal Gas Production, Microbiota and Digestive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been shown that patients complaining of gas-related symptoms significantly improve on&#xD;
      a diet low in fermentable residues. However, other studies suggest that some non-absorbable,&#xD;
      fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce&#xD;
      beneficial effects to the host, including improvement of abdominal symptoms. The aim of the&#xD;
      study is to compare the effects of a diet low in fermentable residues versus a diet&#xD;
      suplemented with prebiotics on intestinal microbiota composition, microbiota activity&#xD;
      (intestinal gas production) and digestive symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Gut microbiota composition</measure>
    <time_frame>28 days</time_frame>
    <description>Effect of treatment on the response of microbiota to 3-day challenge diet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiota activity (intestinal gas production)</measure>
    <time_frame>28 days</time_frame>
    <description>Intestinal gas evacuation on standardized diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive symptoms</measure>
    <time_frame>28 days</time_frame>
    <description>Digestive sensations measured by scales</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Functional Gastrointestinal Disorders</condition>
  <arm_group>
    <arm_group_label>Bimuno Galacto-oligosaccharide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low- FODMAPs diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Dietary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bimuno Galacto-oligosaccharide 1.37 g/d</intervention_name>
    <description>Prebiotic versus low-FODMAPs diet</description>
    <arm_group_label>Bimuno Galacto-oligosaccharide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low- FODMAPs diet</intervention_name>
    <arm_group_label>Low- FODMAPs diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Functional digestive disorder with flatulence&#xD;
&#xD;
          -  Women and men between the ages of 18 and 80 years (bounds included at the inclusion&#xD;
             visit).&#xD;
&#xD;
          -  Normal body weight or with overweight (body mass index between 18.0 and 30.0 kg/m2&#xD;
             (bounds included)).&#xD;
&#xD;
          -  Women of childbearing potential should be using or complying with one of the medically&#xD;
             approved methods of contraception such as, but not exclusively, one of the following:&#xD;
&#xD;
               1. Birth control pill&#xD;
&#xD;
               2. Intra-uterine device (IUD)&#xD;
&#xD;
               3. Double barrier methods (such as condoms and spermicide)&#xD;
&#xD;
               4. Abstinence&#xD;
&#xD;
          -  Willing to follow strict dietary instructions for the duration of the study&#xD;
&#xD;
          -  Able to communicate well with the investigator and to comply with the requirements for&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant illness other than functional bowel disorders&#xD;
&#xD;
          -  Disease/disorders which can interfere with the collection of the gas&#xD;
             (hemorrhoids,..etc)&#xD;
&#xD;
          -  Antecedents of digestive surgery, excluding appendicectomy&#xD;
&#xD;
          -  Intake of antibiotics in the month (within 30 days) preceding the inclusion visit.&#xD;
&#xD;
          -  Current use of any medications with potential central nervous system effects as judged&#xD;
             by the investigator (including but not limited to antidepressants, anxiolytics, opiate&#xD;
             pain medications)&#xD;
&#xD;
          -  Taking drugs that might modify gastrointestinal function&#xD;
&#xD;
          -  Change of dietary habits within the preceding 4 weeks (for instance start of a diet&#xD;
             high in fiber) or planned change (For example to start a diet) during the period of&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Azpiroz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d'Hebron Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vall d'Hebron Research Institute</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>November 27, 2015</last_update_submitted>
  <last_update_submitted_qc>November 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intestinal microbiota</keyword>
  <keyword>Intestinal gas</keyword>
  <keyword>Dietary intervention</keyword>
  <keyword>Low-FODMAPs diet</keyword>
  <keyword>Prebiotics</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>
  </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/NCT02210572
org study id: PR(AG)296/2013/A-4/2014
nct id: NCT02210572
lead sponsor: 
has dmc: No
It has been shown that patients complaining of gas-related symptoms significantly improve on
      a diet low in fermentable residues. However, other studies suggest that some non-absorbable,
      fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce
      beneficial effects to the host, including improvement of abdominal symptoms. The aim of the
      study is to compare the effects of a diet low in fermentable residues versus a diet
      suplemented with prebiotics on intestinal microbiota composition, microbiota activity
      (intestinal gas production) and digestive symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gut microbiota composition
time frame: 28 days
description: Effect of treatment on the response of microbiota to 3-day challenge diet
measure: Microbiota activity (intestinal gas production)
time frame: 28 days
description: Intestinal gas evacuation on standardized diet
measure: Digestive symptoms
time frame: 28 days
description: Digestive sensations measured by scales
arm group label: Bimuno Galacto-oligosaccharide
arm group type: Experimental
description: Dietary intervention
arm group label: Low- FODMAPs diet
arm group type: Placebo Comparator
description: Dietary intervention
intervention type: Dietary Supplement
intervention name: Bimuno Galacto-oligosaccharide 1.37 g/d
description: Prebiotic versus low-FODMAPs diet
arm group label: Bimuno Galacto-oligosaccharide
intervention type: Dietary Supplement
intervention name: Low- FODMAPs diet
arm group label: Low- FODMAPs diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Fernando Azpiroz, MD
role: Principal Investigator
affiliation: Vall d'Hebron Research Institute
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases