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

NCT01268618 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sprim Advanced Life Sciences

    lead OTHER

Principal Investigators

  • Duane Wombolt, MD · Clinical Research Associates of Tidewater

  • David Wyatt, MD · In-Quest Medical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

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 NCT01268618 on ClinicalTrials.gov