Probiotic (Visbiome) for Gulf War Illness

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gulf War Illness

In brief

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.

Key facts

Study ID

NCT03078530

Run by

Ashok Tuteja

People needed

60

Starts

2013-09-13

Expected to finish

2018-05-31

Last updated by the study team

2017-12-13

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• George E Wahlen VA Medical Center — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.