Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2013-09-13
2018-05-31
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo (not an active drug/ Inactive component) is given to this group
Placebo
This is a pill with inactive ingredients
Visbiome
Visbiome (probiotic mixture) is given to this group.
Visbiome
This is a probiotic mixture available to randomized study participants, starting with subject 29
VSL #3
VSL #3 (probiotic mixture) is given to this group
VSL#3
This is a probiotic mixture available to the first 28 subjects randomized to the study
Interventions
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Placebo
This is a pill with inactive ingredients
Visbiome
This is a probiotic mixture available to randomized study participants, starting with subject 29
VSL#3
This is a probiotic mixture available to the first 28 subjects randomized to the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
75 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Ashok Tuteja
FED
Responsible Party
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Ashok Tuteja
Professor Gastroenterology
Principal Investigators
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Ashok Tuteja, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
George E Wahlen VA Medical Center
Locations
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George E Wahlen VA Medical Center
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Ashok Tuteja,, MD, MPH
Role: primary
Jaya Vijayan, MBBS
Role: backup
Other Identifiers
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IRB_00059006
Identifier Type: -
Identifier Source: org_study_id