NCT01268618

Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia

A Double-blind, Randomized, Placebo-controlled, Dual-center Study on the Effect of Healthy Trinity (Retail Label)/Trenev Trio (Professional Label) on Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) and Functional Dyspepsia

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sprim Advanced Life Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia Secondary Objective: • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia

Conditions

• IBS-D and Functional Dyspepsia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of: 1. Lactobacillus acidophilus NAS, 30 billion CFU 2. Bifidobacterium bifidum Malyoth, 120 billion CFU 3. Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU
DIETARY_SUPPLEMENT	Placebo	2 capsules, 3x/day placebo capsules

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-12-31
• Last updated: 2011-07-21

Locations

2 sites across 1 country: United States