NCT02011542

Probiotic (VSL #3) for Gulf War Illness

Probiotics (VSL #3) for Gulf War Illness

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The overall objective is to determine whether VSL #3 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 VSL #3 on IBS symptoms in GW veterans. Hypothesis: Treatment with VSL #3 compared to placebo will improve global and individual symptoms of IBS Aim #2 Determine the efficacy VSL #3 in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache). Hypothesis: Treatment with VSL #3 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	VSL#3	This is a probiotic mixture
DRUG	Placebo	This is a pill with inactive ingredients.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-12-13
• Last updated: 2018-10-26
• Results posted: 2018-01-16

Locations

1 site across 1 country: United States