<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/NCT03277157</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701976</org_study_id>
    <nct_id>NCT03277157</nct_id>
  </id_info>
  <brief_title>B. Lactis B94 Effects of Gastrointestinal Function</brief_title>
  <official_title>The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lallemand Health Solutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</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 aim of this study is to determine the effect of daily consumption of Bifidobacterium&#xD;
      animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit&#xD;
      time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75&#xD;
      years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled,&#xD;
      crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a&#xD;
      4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants&#xD;
      will complete daily questionnaires about stool frequency and stool form (transit). Dietary&#xD;
      intake will also be assessed. A total of 5 stools (one in each period) will be collected for&#xD;
      exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase&#xD;
      stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Probiotics have been shown to improve symptoms of constipation by decreasing gastrointestinal&#xD;
      transit time, increasing stool frequency, and normalizing stool form. A 20-week randomized,&#xD;
      double-blinded, placebo-controlled crossover study will be carried out. Participants will&#xD;
      complete a 4-week baseline period during which stool frequency, stool consistency (transit&#xD;
      time), and gastrointestinal symptoms will be collected by paper questionnaire, and&#xD;
      participants will collect a single stool. Dietary intake data (3-day) will be obtained during&#xD;
      the baseline period. Participants will be randomized on or about day 29 and will consume&#xD;
      Bifidobacterium animalis ssp lactis B94 (B. lactis B94) or placebo for 4 weeks, followed by a&#xD;
      4-week washout, 4 weeks on the alternative, and second 4-week washout. Participants will be&#xD;
      randomized by sealed envelope method, prepared by a UF faculty member not affiliated with the&#xD;
      study.&#xD;
&#xD;
      During the intervention and washout periods, participants will complete daily questionnaires&#xD;
      to assess stool frequency and form (Bristol Stool Form Scale). Furthermore, they will&#xD;
      complete Gastrointestinal Symptom Rating Scale (GSRS) at weeks 4, 8, 12, 16 and 20(± 3 days).&#xD;
      During these same weeks (± 3 days) dietary intake data (28-day record) and stools will be&#xD;
      collected (1 per period). Participants' height and weight will be taken at baseline, and&#xD;
      weight during weeks 4, 8, 12, 16 and 20.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The B. lactis and placebo will be provided in identical capsules.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stool frequency</measure>
    <time_frame>4 weeks</time_frame>
    <description>Weekly stool frequency - difference between treatments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stool frequency percentage change</measure>
    <time_frame>4 weeks</time_frame>
    <description>Weekly stool frequency: percentage change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bristol Stool Form</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percentage slow transit (Bristol Stool Form Scale 1 and 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>4 weeks</time_frame>
    <description>&gt;80% of supplement intake</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo veggie capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>B. lactis B94</intervention_name>
    <description>A probiotic dose of 15 billion per capsule.</description>
    <arm_group_label>Probiotic</arm_group_label>
    <other_name>Bifidobacterium animalis ssp lactis B94</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are willing and able to provide informed consent.&#xD;
&#xD;
          -  Have confirmed diagnosis of PWS&#xD;
&#xD;
          -  Are willing to have height and weight measured and provide demographic information&#xD;
             (e.g. age, race, sex)&#xD;
&#xD;
          -  Are 18-75 years of age&#xD;
&#xD;
          -  Are willing to consume B. lactis B94 and placebo each for 4-week periods&#xD;
&#xD;
          -  Are willing to complete a daily questionnaire throughout the 20-week period.&#xD;
&#xD;
          -  Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) monthly&#xD;
             throughout the 20-week study&#xD;
&#xD;
          -  Are willing to provide information about their dietary intake for 3-days every 4 weeks&#xD;
&#xD;
          -  Are willing to provide a valid social security for study payment purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a milk protein allergy&#xD;
&#xD;
          -  Are currently taking medications for diarrhea&#xD;
&#xD;
          -  Are currently taking probiotics supplements and do not want to discontinue prior to&#xD;
             the start of the baseline period (i.e. those that discontinue will be included)&#xD;
&#xD;
          -  Have previously or are currently being treated for any gastrointestinal diseases such&#xD;
             as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy J Dahl, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ARC of Alachua County</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Pediatrics - Gerold L. Schiebler CMS Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Food Science and Human Nutrition Department, University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03277157
org study id: IRB201701976
nct id: NCT03277157
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the effect of daily consumption of Bifidobacterium
      animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit
      time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75
      years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled,
      crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a
      4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants
      will complete daily questionnaires about stool frequency and stool form (transit). Dietary
      intake will also be assessed. A total of 5 stools (one in each period) will be collected for
      exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase
      stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms
Probiotics have been shown to improve symptoms of constipation by decreasing gastrointestinal
      transit time, increasing stool frequency, and normalizing stool form. A 20-week randomized,
      double-blinded, placebo-controlled crossover study will be carried out. Participants will
      complete a 4-week baseline period during which stool frequency, stool consistency (transit
      time), and gastrointestinal symptoms will be collected by paper questionnaire, and
      participants will collect a single stool. Dietary intake data (3-day) will be obtained during
      the baseline period. Participants will be randomized on or about day 29 and will consume
      Bifidobacterium animalis ssp lactis B94 (B. lactis B94) or placebo for 4 weeks, followed by a
      4-week washout, 4 weeks on the alternative, and second 4-week washout. Participants will be
      randomized by sealed envelope method, prepared by a UF faculty member not affiliated with the
      study.

      During the intervention and washout periods, participants will complete daily questionnaires
      to assess stool frequency and form (Bristol Stool Form Scale). Furthermore, they will
      complete Gastrointestinal Symptom Rating Scale (GSRS) at weeks 4, 8, 12, 16 and 20(± 3 days).
      During these same weeks (± 3 days) dietary intake data (28-day record) and stools will be
      collected (1 per period). Participants' height and weight will be taken at baseline, and
      weight during weeks 4, 8, 12, 16 and 20.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The B. lactis and placebo will be provided in identical capsules.
measure: Stool frequency
time frame: 4 weeks
description: Weekly stool frequency - difference between treatments
measure: Stool frequency percentage change
time frame: 4 weeks
description: Weekly stool frequency: percentage change from baseline
measure: Bristol Stool Form
time frame: 4 weeks
description: Percentage slow transit (Bristol Stool Form Scale 1 and 2)
measure: Gastrointestinal symptoms
time frame: 4 weeks
description: Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)
measure: Compliance
time frame: 4 weeks
description: >80% of supplement intake
arm group label: Probiotic
arm group type: Experimental
description: Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo veggie capsule.
intervention type: Dietary Supplement
intervention name: B. lactis B94
description: A probiotic dose of 15 billion per capsule.
arm group label: Probiotic
other name: Bifidobacterium animalis ssp lactis B94
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo capsule
arm group label: Placebo
other name: Placebo capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wendy J Dahl, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided