Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms
NCT02277431 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-09-14
Summary
Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.
Conditions
- Gastrointestinal Symptoms
- Bloating
- Gas
- Indigestion
- Abdominal Pain
- Defecation Irregularity
Interventions
- DIETARY_SUPPLEMENT
-
Probiotic dietary supplement (Trenev Trio®)
Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am \& pm) offering a total daily serving of: * Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units \[CFU\]) * Bifidobacterium bifidum Malyoth super strain (40 billion CFU) * Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)
- DIETARY_SUPPLEMENT
-
placebo
Sponsors & Collaborators
-
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Chris D'Adamo, PhD · University of Maryland, College Park
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-10-31
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