Status:
COMPLETED
B. Lactis B94 Effects of Gastrointestinal Function
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
Quality of Life
Eligibility:
All Genders
18-75 years
Phase:
NA
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 gastrointes...
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...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03277157
Start Date
December 8 2017
End Date
July 17 2019
Last Update
August 28 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
ARC of Alachua County
Gainesville, Florida, United States, 32606
2
UF Health Pediatrics - Gerold L. Schiebler CMS Center
Gainesville, Florida, United States, 32608
3
Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, United States, 32611