B. Lactis B94 Effects of Gastrointestinal Function

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03277157
• Date of registration: 07/09/2017
• Prospective Registration: Yes
• Primary sponsor: University of Florida
• Public title: B. Lactis B94 Effects of Gastrointestinal Function
• Scientific title: The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study
• Date of first enrolment: December 8, 2017
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03277157
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Wendy J Dahl, PhD
• Affiliation: University of Florida

Key inclusion & exclusion criteria

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.).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Quality of Life

Intervention(s)

Dietary Supplement: B. lactis B94

Dietary Supplement: Placebo

Primary Outcome(s)

Stool frequency [Time Frame: 4 weeks]

Secondary Outcome(s)

Gastrointestinal symptoms [Time Frame: 4 weeks]

Stool frequency percentage change [Time Frame: 4 weeks]

Compliance [Time Frame: 4 weeks]

Bristol Stool Form [Time Frame: 4 weeks]

Secondary ID(s)

IRB201701976

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lallemand Health Solutions