NCT02277431

Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

A Randomized Controlled Trial of a Commercially-Available Probiotic Supplement (Trenev Trio®/Healthy Trinity®) and the Promotion of Normal Gastrointestinal Function Among Adults With Recurrent Gastrointestinal Symptoms

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2014-10-29
• Last updated: 2021-09-14