Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

NCT02277431 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-14

No results posted yet for this study

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

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277431 on ClinicalTrials.gov