An interventional study of B. lactis B94 and Placebo in Quality of Life, sponsored by University of Florida. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by University of Florida · Not applicable, Interventional, and Other
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
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.
Exclusion Criteria:
Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule
Dietary Supplement: B. lactis B94
Placebo veggie capsule.
Dietary Supplement: Placebo
A probiotic dose of 15 billion per capsule.
Also known as: Bifidobacterium animalis ssp lactis B94
Placebo capsule
Also known as: Placebo capsule
Stool frequency
Weekly stool frequency - difference between treatments
Time frame: 4 weeks
Stool frequency percentage change
Weekly stool frequency: percentage change from baseline
Time frame: 4 weeks
Bristol Stool Form
Percentage slow transit (Bristol Stool Form Scale 1 and 2)
Time frame: 4 weeks
Gastrointestinal symptoms
Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 4 weeks
Compliance
\>80% of supplement intake
Time frame: 4 weeks
Plan to share: Undecided
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of Florida