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Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

NCT01444859 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-10-24

No results posted yet for this study

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.

Conditions

  • Recurrent Gastrointestinal Symptoms

Interventions

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

Sponsors & Collaborators

  • The National Institute of Probiotics

    collaborator OTHER

  • Sprim Advanced Life Sciences

    lead OTHER

Principal Investigators

  • Duane Wombolt, MD · Clinical Research Associates of Tidewater

  • Jeffrey Stewart, MD · Research Across America

  • Michael Sinitsa, MD · Research Across America

  • Helen Stacey, MD · Diablo Clinical Research

  • Lydie Hazan, MD · Axis Clinical Trials

  • JoAnn Hattner, MPH, RD · Sprim ALS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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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 NCT01444859 on ClinicalTrials.gov