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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
29
George E Wahlen VA Medical Center
Salt Lake City, Utah, United States
Improvement in the Bowel Symptom Scale (BSS) From Baseline
Efficacy of VSL #3 in Irritable Bowel Syndrome (IBS) related symptoms in Gulf War illness is measured using BSS at 2, 4, 6, 8 wks
Time frame: 8 weeks
Change in Chronic Fatigue (1-5 Scale) From Baseline
Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.