Probiotic (Visbiome) for Gulf War Illness

Phase 2

• Conditions: Gulf War Illness
• Interventions: Drug: Placebo; Drug: Visbiome; Drug: VSL#3

• Registration Number: NCT03078530
• Lead Sponsor: Ashok Tuteja

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

Study Timeline

• Study Start: 2013-09-13
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (not an active drug/ Inactive component) is given to this group
Visbiome	Visbiome	Visbiome (probiotic mixture) is given to this group.
VSL #3	VSL#3	VSL #3 (probiotic mixture) is given to this group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in chronic fatigue (1-5 scale) from baseline	baseline to 8 weeks	Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 8 weeks.

Trial Locations

Locations (1)

George E Wahlen VA Medical Center; 🇺🇸 Salt Lake City, Utah, United States