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B. Lactis B94 Effects of Gastrointestinal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03277157
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : August 28, 2019
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Quality of Life Dietary Supplement: B. lactis B94 Dietary Supplement: Placebo Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The B. lactis and placebo will be provided in identical capsules.
Primary Purpose: Other
Official Title: The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study
Actual Study Start Date : December 8, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : July 17, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Probiotic
Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule
Dietary Supplement: B. lactis B94
A probiotic dose of 15 billion per capsule.
Other Name: Bifidobacterium animalis ssp lactis B94

Placebo Comparator: Placebo
Placebo veggie capsule.
Dietary Supplement: Placebo
Placebo capsule
Other Name: Placebo capsule

Primary Outcome Measures :
  1. Stool frequency [ Time Frame: 4 weeks ]
    Weekly stool frequency - difference between treatments

Secondary Outcome Measures :
  1. Stool frequency percentage change [ Time Frame: 4 weeks ]
    Weekly stool frequency: percentage change from baseline

  2. Bristol Stool Form [ Time Frame: 4 weeks ]
    Percentage slow transit (Bristol Stool Form Scale 1 and 2)

  3. Gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)

  4. Compliance [ Time Frame: 4 weeks ]
    >80% of supplement intake

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are willing and able to provide informed consent.
  • Have confirmed diagnosis of PWS
  • Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
  • Are 18-75 years of age
  • Are willing to consume B. lactis B94 and placebo each for 4-week periods
  • Are willing to complete a daily questionnaire throughout the 20-week period.
  • Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) monthly throughout the 20-week study
  • Are willing to provide information about their dietary intake for 3-days every 4 weeks
  • Are willing to provide a valid social security for study payment purposes

Exclusion Criteria:

  • Have a milk protein allergy
  • Are currently taking medications for diarrhea
  • Are currently taking probiotics supplements and do not want to discontinue prior to the start of the baseline period (i.e. those that discontinue will be included)
  • Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03277157

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United States, Florida
ARC of Alachua County
Gainesville, Florida, United States, 32606
UF Health Pediatrics - Gerold L. Schiebler CMS Center
Gainesville, Florida, United States, 32608
Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Health Solutions
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Principal Investigator: Wendy J Dahl, PhD University of Florida
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Florida Identifier: NCT03277157    
Other Study ID Numbers: IRB201701976
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No