Gulf War Illness
Conditions
Keywords
GWI, IBS, Irritable Bowel Syndrome, Gulf War Illness, Probiotics
Brief summary
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.
Detailed description
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
Interventions
DRUGPlacebo
This is a pill with inactive ingredients
DRUGVisbiome
This is a probiotic mixture available to randomized study participants, starting with subject 29
DRUGVSL#3
This is a probiotic mixture available to the first 28 subjects randomized to the study
Sponsors
United States Department of Defense
Ashok Tuteja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. First GW veterans, Men and women age 35-75 years, 2. 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) 3. Symptoms of \> 6 months duration, 4. No significant findings on physical examination, Complete Blood Count (CBC) and clinical chemistry panel. 5. Normal gross appearance of the colonic mucosa other than erythema and polyps 6. Negative Tissue transglutaminase (TTG) for celiac disease, 7. Normal thyroid function. 8. Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis. 9. Stable medication regimen for more than a month
Exclusion criteria
1. Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease 2. 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 3. Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction. 4. Presence of Giardia antigen, and Clostridium difficile toxin in stool, 5. Abnormal blood test for thyroid stimulating hormone, tissue transglutaminase antibody 6. Current effects of drug or alcohol abuse 7. Investigator perception of patient's inability to comply with study protocol 8. Recent change in gastrointestinal medications 9. Use of any antibiotic in the last 1 months 10. Positive pregnancy test 11. Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the bowel symptom scale from the baseline | Baseline to 8 weeks | Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in chronic fatigue (1-5 scale) from baseline | baseline to 4 weeks | Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 4 weeks. |
Countries
United States
Contacts
Primary ContactAshok Tuteja, MD, MPH
Backup ContactJaya Vijayan, MBBS
Outcome results
None listed