Conditions: Gulf War Illness
Keywords: Irritable Bowel Syndrome Gulf War Illness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Placebo (not an active drug/ Inactive component) is given to this group arm 2: VSL #3 (probiotic mixture) is given to this group

Interventions: intervention 1: VSL#3 intervention 2: Placebo
Intervention descriptions: intervention 1: This is a probiotic mixture intervention 2: This is a pill with inactive ingredients.

Protocol document: