<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/NCT02189707</url>
  </required_header>
  <id_info>
    <org_study_id>Bifido transit 3</org_study_id>
    <nct_id>NCT02189707</nct_id>
  </id_info>
  <brief_title>Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation.</brief_title>
  <official_title>Effects of 4-week Bifidobacterium-lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danisco Sweeteners Oy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eurofins Optimed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Danisco Sweeteners Oy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal&#xD;
      symptoms in adults with constipation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence&#xD;
      in the general population of 12-19%, which results in lower quality of life and significant&#xD;
      healthcare costs to the individual. Almost 9 in 10 physician visits for constipation result&#xD;
      in a laxative prescription. Additionally, consumers in the USA and in the United Kingdom&#xD;
      spend almost 1 billion dollars annually for over-the-counter laxatives. Chronic constipation&#xD;
      is diagnosed almost solely on patient symptoms, which generally includes unsatisfactory&#xD;
      defecation due to infrequent stools, difficult stool passage, or both. The cause of chronic&#xD;
      constipation is unknown and likely multifactorial with physiological changes, psychological&#xD;
      factors, and lifestyle influences identified as possible culprits. Consequently,&#xD;
      identification of effective constipation treatments remains a challenge.&#xD;
&#xD;
      The initial management of constipation symptoms is focused on evaluating lifestyle and diet&#xD;
      variables as possible culprits. If lifestyle modifications are unsuccessful in alleviating&#xD;
      constipation, various medications may be prescribed. In fact, about 50% of adults with&#xD;
      constipation are not completely satisfied with available treatments. Consequently, there is a&#xD;
      clear need for alternative constipation treatments that are safe, effective, and&#xD;
      cost-effective.&#xD;
&#xD;
      Probiotics are live micro-organisms that result in a health benefit for the host when&#xD;
      administered in adequate dosages. In recent years, probiotics have been commonly used to&#xD;
      alleviate symptoms in a variety of gastrointestinal disorders. It is hypothesized that&#xD;
      probiotics help to maintain gut lumen homeostasis by hindering growth of luminal pathogens&#xD;
      and restoring the normal flora of the gut. As such, the use of probiotics for the relief of&#xD;
      constipation symptoms is very promising. Numerous studies have been published addressing the&#xD;
      utility of probiotics for gastrointestinal health including constipation. However, since&#xD;
      probiotic efficacy is largely strain-specific, each specific strain must be individually&#xD;
      tested in clinical trials.&#xD;
&#xD;
      Given the promising clinical results of probiotics on gastrointestinal health to date, the&#xD;
      objective of this clinical trial is to evaluate the safety and effectiveness of 4-week&#xD;
      Bifidobacterium lactis HN019 supplementation, in a dose-ranging fashion, on Colonic Transit&#xD;
      Time (CTT) and gastrointestinal symptoms in adults with constipation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Colonic transit time</measure>
    <time_frame>The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient (syn. participant) assessment of constipation symptoms (PAC-SYM)</measure>
    <time_frame>At days 0 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment of Constipation Quality of Life (PAC-QoL)</measure>
    <time_frame>At days 0 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel Function Index</measure>
    <time_frame>At days 0 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate Relief of constipation (yes/no)</measure>
    <time_frame>At days 0 and 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel movement frequency stools per week)</measure>
    <time_frame>Participants will record the number of defecations per day in a daily diary during the 2-week run-in period and each day during the 4-week supplementation period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency (Bristol Stool Scale)</measure>
    <time_frame>Participants will record stool consistency during the 2-week run-in period and each day during the 4-week supplementation period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of Straining (1-5 scale)</measure>
    <time_frame>Participants will record degree of straining during the 2-week run-in period and each day during the 4-week supplementation period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant assessment of bowel emptying (yes/no)</measure>
    <time_frame>Participants will record sensation of complete bowel emptying during the 2-week run-in period and each day during the 4-week supplementation period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal discomfort/bloating (1-5 scale)</measure>
    <time_frame>Participants will record severity of abdominal discomfort and bloating during the 2-week run-in period and each day during the 4-week supplementation period.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall product satisfaction (1-5 scale)</measure>
    <time_frame>At the end of the supplementation period (D28)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">228</enrollment>
  <condition>Constipation</condition>
  <condition>Gastrointestinal Disorder</condition>
  <arm_group>
    <arm_group_label>Probiotic Bifidobacterium 1x1010 cfu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule of study product, mixed with provided yogurt, will be consumed once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic Bifidobacterium 1x109 cfu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule of study product, mixed with provided yogurt, will be consumed once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo powder in capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One capsule of study product, mixed with provided yogurt, will be consumed once a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic Bifidobacterium 1x1010 cfu</intervention_name>
    <description>Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.</description>
    <arm_group_label>Probiotic Bifidobacterium 1x1010 cfu</arm_group_label>
    <other_name>Probiotic powder (1 x1010 cfu B. lactis HN019) in capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic Bifidobacterium 1x109 cfu</intervention_name>
    <description>Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.</description>
    <arm_group_label>Probiotic Bifidobacterium 1x109 cfu</arm_group_label>
    <other_name>Probiotic powder (1 x 109 cfu B. lactis HN019) in capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo powder in capsules</intervention_name>
    <description>Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.</description>
    <arm_group_label>Placebo powder in capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Age 18 to 70 years&#xD;
&#xD;
          -  2.Body mass index between 18.5 and 34.9 kg/m2&#xD;
&#xD;
          -  3. Meets the Rome III criteria for functional constipation as follows: (Criteria&#xD;
             fulfilled for the last 3 months with symptom onset at least 6 months prior to&#xD;
             diagnosis):&#xD;
&#xD;
               -  Must meet 2 or more of the following criteria:&#xD;
&#xD;
                    -  Straining during at least 25% of defecations&#xD;
&#xD;
                    -  Lumpy or hard stools in at least 25% of defecations&#xD;
&#xD;
                    -  Sensation of incomplete evacuation for at least 25% of defecations&#xD;
&#xD;
                    -  Sensation of anorectal obstruction/blockage for at least 25% of defecations+&#xD;
                       Manual maneuvers to facilitate at least 25% of defecations (e.g., digital&#xD;
                       evacuation, support of the pelvic floor)&#xD;
&#xD;
                    -  Fewer than three defecations per week&#xD;
&#xD;
               -  Loose stools are rarely present without the use of laxatives&#xD;
&#xD;
               -  Insufficient criteria for irritable bowel syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Major gastrointestinal complication (e.g. Crohn's disease, ulcer)&#xD;
&#xD;
          -  2. Prior abdominal surgery that, in the opinion of the investigator, may present a&#xD;
             risk for the participant or confound study results&#xD;
&#xD;
          -  3. Clinically significant underlying systemic illness that may preclude the&#xD;
             participant's ability to complete the trial or that may confound the study outcomes&#xD;
             (e.g. bowel cancer, prostate cancer, terminal illness)&#xD;
&#xD;
          -  4. Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2&#xD;
             weeks of screening and throughout the trial other than the provided study products&#xD;
&#xD;
          -  5. Laxative use within 48 hours of screening (rescue medication allowed for&#xD;
             intolerable symptoms during study)&#xD;
&#xD;
          -  6. Regular use of any drug or dietary supplement known to cause constipation (e.g.&#xD;
             iron, opioids, sucralfate, misoprostol, 5-Hydroxytryptamine#-antagonists, antacids&#xD;
             with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents,&#xD;
             calcium supplements, calcium channel blockers, tricyclic antidepressants or&#xD;
             nonsteroidal antiinflammatory drugs), within 1 month before screening.&#xD;
&#xD;
          -  7. Anticipated major dietary or exercise changes during the study&#xD;
&#xD;
          -  8. Systemic steroid use, within 1 month before screening.&#xD;
&#xD;
          -  9. Eating disorder&#xD;
&#xD;
          -  10. Contraindication to dairy products (e.g., intolerance to lactose or any substance&#xD;
             in the study product)&#xD;
&#xD;
          -  11. History of alcohol, drug, or medication abuse&#xD;
&#xD;
          -  12. Pregnant or lactating female, or pregnancy planned during study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathilde Latreille-Barbier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eurofins Optimed</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EUROFINS OPTIMED Clinical Research</name>
      <address>
        <city>Gières</city>
        <zip>38610</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>May 6, 2015</last_update_submitted>
  <last_update_submitted_qc>May 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal disorder</keyword>
  <keyword>Constipation</keyword>
  <keyword>Probiotics</keyword>
  <keyword>Dietary supplement</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>Constipation</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/NCT02189707
org study id: Bifido transit 3
nct id: NCT02189707
lead sponsor: 
collaborator: 
has dmc: No
To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal
      symptoms in adults with constipation.
Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence
      in the general population of 12-19%, which results in lower quality of life and significant
      healthcare costs to the individual. Almost 9 in 10 physician visits for constipation result
      in a laxative prescription. Additionally, consumers in the USA and in the United Kingdom
      spend almost 1 billion dollars annually for over-the-counter laxatives. Chronic constipation
      is diagnosed almost solely on patient symptoms, which generally includes unsatisfactory
      defecation due to infrequent stools, difficult stool passage, or both. The cause of chronic
      constipation is unknown and likely multifactorial with physiological changes, psychological
      factors, and lifestyle influences identified as possible culprits. Consequently,
      identification of effective constipation treatments remains a challenge.

      The initial management of constipation symptoms is focused on evaluating lifestyle and diet
      variables as possible culprits. If lifestyle modifications are unsuccessful in alleviating
      constipation, various medications may be prescribed. In fact, about 50% of adults with
      constipation are not completely satisfied with available treatments. Consequently, there is a
      clear need for alternative constipation treatments that are safe, effective, and
      cost-effective.

      Probiotics are live micro-organisms that result in a health benefit for the host when
      administered in adequate dosages. In recent years, probiotics have been commonly used to
      alleviate symptoms in a variety of gastrointestinal disorders. It is hypothesized that
      probiotics help to maintain gut lumen homeostasis by hindering growth of luminal pathogens
      and restoring the normal flora of the gut. As such, the use of probiotics for the relief of
      constipation symptoms is very promising. Numerous studies have been published addressing the
      utility of probiotics for gastrointestinal health including constipation. However, since
      probiotic efficacy is largely strain-specific, each specific strain must be individually
      tested in clinical trials.

      Given the promising clinical results of probiotics on gastrointestinal health to date, the
      objective of this clinical trial is to evaluate the safety and effectiveness of 4-week
      Bifidobacterium lactis HN019 supplementation, in a dose-ranging fashion, on Colonic Transit
      Time (CTT) and gastrointestinal symptoms in adults with constipation.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Colonic transit time
time frame: The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28
measure: Patient (syn. participant) assessment of constipation symptoms (PAC-SYM)
time frame: At days 0 and 28
measure: Patient Assessment of Constipation Quality of Life (PAC-QoL)
time frame: At days 0 and 28
measure: Bowel Function Index
time frame: At days 0 and 28
measure: Adequate Relief of constipation (yes/no)
time frame: At days 0 and 28
measure: Bowel movement frequency stools per week)
time frame: Participants will record the number of defecations per day in a daily diary during the 2-week run-in period and each day during the 4-week supplementation period
measure: Stool consistency (Bristol Stool Scale)
time frame: Participants will record stool consistency during the 2-week run-in period and each day during the 4-week supplementation period.
measure: Degree of Straining (1-5 scale)
time frame: Participants will record degree of straining during the 2-week run-in period and each day during the 4-week supplementation period.
measure: Participant assessment of bowel emptying (yes/no)
time frame: Participants will record sensation of complete bowel emptying during the 2-week run-in period and each day during the 4-week supplementation period.
measure: Abdominal discomfort/bloating (1-5 scale)
time frame: Participants will record severity of abdominal discomfort and bloating during the 2-week run-in period and each day during the 4-week supplementation period.
measure: Overall product satisfaction (1-5 scale)
time frame: At the end of the supplementation period (D28)
arm group label: Probiotic Bifidobacterium 1x1010 cfu
arm group type: Experimental
description: One capsule of study product, mixed with provided yogurt, will be consumed once a day.
arm group label: Probiotic Bifidobacterium 1x109 cfu
arm group type: Experimental
description: One capsule of study product, mixed with provided yogurt, will be consumed once a day.
arm group label: Placebo powder in capsules
arm group type: Placebo Comparator
description: One capsule of study product, mixed with provided yogurt, will be consumed once a day.
intervention type: Dietary Supplement
intervention name: Probiotic Bifidobacterium 1x1010 cfu
description: Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.
arm group label: Probiotic Bifidobacterium 1x1010 cfu
other name: Probiotic powder (1 x1010 cfu B. lactis HN019) in capsules
intervention type: Dietary Supplement
intervention name: Probiotic Bifidobacterium 1x109 cfu
description: Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.
arm group label: Probiotic Bifidobacterium 1x109 cfu
other name: Probiotic powder (1 x 109 cfu B. lactis HN019) in capsules
intervention type: Other
intervention name: Placebo powder in capsules
description: Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.
arm group label: Placebo powder in capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mathilde Latreille-Barbier, MD
role: Principal Investigator
affiliation: Eurofins Optimed
facility: 
country: France
responsible party type: Sponsor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Constipation