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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
George E Wahlen VA Medical Center
Salt Lake City, Utah, United States
RECRUITINGChange in the bowel symptom scale from the baseline
Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks
Time frame: Baseline to 8 weeks
Change in chronic fatigue (1-5 scale) from baseline
Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 4 weeks.
Time frame: baseline to 4 weeks
Change in chronic fatigue (1-5 scale) from baseline
Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 8 weeks.
Time frame: baseline to 8 weeks
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