B. Lactis B94 Effects of Gastrointestinal Function

Completed · Not applicable · Has a placebo group

Conditions studied: Quality of Life

In brief

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

Key facts

Study ID

NCT03277157

Run by

University of Florida

People needed

28

Starts

2017-12-08

Expected to finish

2019-07-17

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.).

Where it is running

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

Full record on ClinicalTrials.gov

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