NCT03078530

Probiotic (Visbiome) for Gulf War Illness

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ashok Tuteja · Federal
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Gulf War Illness

Interventions

Type	Name	Description
DRUG	Placebo	This is a pill with inactive ingredients
DRUG	Visbiome	This is a probiotic mixture available to randomized study participants, starting with subject 29
DRUG	VSL#3	This is a probiotic mixture available to the first 28 subjects randomized to the study

Timeline

• Start date: 2013-09-13
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-03-13
• Last updated: 2017-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study