B. Lactis B94 Effects of Gastrointestinal Function

The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study

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

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: B. lactis B94

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Food Science and Human Nutrition Department, University of Florida
    • Gainesville, Florida, United States, 32606
      • ARC of Alachua County
    • Gainesville, Florida, United States, 32608
      • UF Health Pediatrics - Gerold L. Schiebler CMS Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Bifidobacterium animalis ssp lactis B94
PLACEBO_COMPARATOR: Placebo; Placebo veggie capsule.	Dietary supplement: Placebo; Placebo capsule; Other Names: Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Weekly stool frequency - difference between treatments	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency percentage change	Weekly stool frequency: percentage change from baseline	4 weeks
Bristol Stool Form	Percentage slow transit (Bristol Stool Form Scale 1 and 2)	4 weeks
Gastrointestinal symptoms	Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)	4 weeks
Compliance	>80% of supplement intake	4 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Lallemand Health Solutions

Publications and helpful links

General Publications

• Alyousif Z, Miller JL, Sandoval MY, MacPherson CW, Nagulesapillai V, Dahl WJ. The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial. Trials. 2018 Apr 27;19(1):256. doi: 10.1186/s13063-018-2648-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2017
• Primary Completion (ACTUAL): October 31, 2018
• Study Completion (ACTUAL): July 17, 2019

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB201701976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No