Probiotic (VSL #3) for Gulf War Illness (NCT02011542) | Clinical Trial Compass
TerminatedPhase 2/3
Probiotic (VSL #3) for Gulf War Illness
Stopped: Original study product (VSL #3) became unavailable; change in study Collaborator and product
United States29 participantsStarted 2013-09
Plain-language 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.
Who can participate
Age range35 Years – 75 Years
SexALL
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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.
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