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Clinical Trial Summary

The overall objective is to determine whether Visbiome will improve

1. intestinal symptoms of Irritable Bowel Syndrome (IBS) and

2. non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.


Clinical Trial Description

Specific Aims:

Aim # 1: Determine the efficacy of Visbiome on IBS symptoms in GW veterans.

Hypothesis: Treatment with Visbiome compared to placebo will improve global and individual symptoms of IBS

Aim #2 Determine the efficacy Visbiome in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).

Hypothesis: Treatment with Visbiome compared to placebo will improve non-intestinal symptoms of IBS in GW veterans.

Aim #3 Determine whether changes in gut flora and plasma cytokines correlate with treatment response in GW veterans ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03078530
Study type Interventional
Source VA Salt Lake City Health Care System
Contact Ashok Tuteja, MD, MPH
Phone 8015821565
Email ashok.tuteja@va.gov
Status Recruiting
Phase Phase 2/Phase 3
Start date September 13, 2013
Completion date May 31, 2018

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