Probiotic (Visbiome) for Gulf War Illness

Study Overview
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Brief Summary
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The overall objective is to determine whether Visbiome will improve intestinal symptoms of Irritable Bowel Syndrome (IBS) and 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
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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

Official Title
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Probiotic (Visbiome) for Gulf War Illness

Conditions
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Gulf War Illness

Intervention / Treatment
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* Drug: Placebo
* Drug: Visbiome
* Drug: VSL#3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First GW veterans, Men and women age 35-75 years, Rome III criteria for IBS and two or more of the non-intestinal symptoms (chronic-once a week or more often-fatigue, joint pains, insomnia, general stiffness, and headache) Symptoms of > 6 months duration, No significant findings on physical examination, Complete Blood Count (CBC) and clinical chemistry panel. Normal gross appearance of the colonic mucosa other than erythema and polyps Negative Tissue transglutaminase (TTG) for celiac disease, Normal thyroid function. Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis. Stable medication regimen for more than a month Exclusion Criteria: Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease History of/or presence of systemic malignancy (patients with skin and other cancers in remission for more than 5 years are allowed in the study Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction. Presence of Giardia antigen, and Clostridium difficile toxin in stool, Abnormal blood test for thyroid stimulating hormone, tissue transglutaminase antibody Current effects of drug or alcohol abuse Investigator perception of patient's inability to comply with study protocol Recent change in gastrointestinal medications Use of any antibiotic in the last 1 months Positive pregnancy test Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (not an active drug/ Inactive component) is given to this group | Drug: Placebo<br>* This is a pill with inactive ingredients<br>* Other names: Placebo/ Sugar pill;|
| Experimental: Visbiome<br>Visbiome (probiotic mixture) is given to this group. | Drug: Visbiome<br>* This is a probiotic mixture available to randomized study participants, starting with subject 29<br>|
| Experimental: VSL #3<br>VSL #3 (probiotic mixture) is given to this group | Drug: VSL#3<br>* This is a probiotic mixture available to the first 28 subjects randomized to the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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 | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GWI, IBS, Irritable Bowel Syndrome, Gulf War Illness, Probiotics