NCT01444859

Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study

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

Summary

Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.

Detailed description

This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.

Conditions

• Recurrent Gastrointestinal Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Trenev Trio®/Healthy Trinity®	Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU)
DIETARY_SUPPLEMENT	Placebo	Daily placebo for 10 weeks

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2011-10-03
• Last updated: 2012-10-24

Locations

5 sites across 1 country: United States