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NCT03277157 · ClinicalTrials.gov registry record · NA
B. Lactis B94 Effects of Gastrointestinal Function
A NA study of Quality of Life, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 3
- Study locations
NCT03277157: Completed NA study of Quality of Life, sponsored by University of Florida.
NCT03277157 is a NA study of Quality of Life that has completed, run by University of Florida. The registered enrollment target is 28 participants, below the 452-participant average among 107 other Quality of Life trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03277157, a NA study of Quality of Life, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 3
- Study locations
Study 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 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
Primary Outcome
Weekly stool frequency - difference between treatments
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT B. lactis B94
Study Locations (3)
Florida
- ARC of Alachua County - Gainesville
- UF Health Pediatrics - Gerold L. Schiebler CMS Center - Gainesville
- Food Science and Human Nutrition Department, University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2019-07-17 |
| Phase | NA |
What the finished NCT03277157 record still lists
NCT03277157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 452-participant average among 107 other Quality of Life trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Quality of Life appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03277157 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03277157 about?
NCT03277157 is a clinical study titled "B. Lactis B94 Effects of Gastrointestinal Function". 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 re...
What is the current status of trial NCT03277157?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2017-12-08. Estimated completion is 2019-07-17.
What conditions does trial NCT03277157 study?
This clinical trial studies the following conditions: Quality of Life.
What interventions are being tested in trial NCT03277157?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), B. lactis B94 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03277157?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03277157 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03277157's enrollment target sits among peer trials
28 94th of 107 higher than 13 of 107 other Quality of Life trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Quality of Life trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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