Probiotic (Visbiome) for Gulf War Illness

Gulf War Illness Clinical Trial

Official title:

Probiotic (Visbiome) for Gulf War Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03078530
• Other study ID #: IRB_00059006
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 8, 2017
• Last updated: December 11, 2017
• Start date: September 13, 2013
• Est. completion date: May 31, 2018

Study information

• Verified date: December 2017
• Source: VA Salt Lake City Health Care System
• Contact: Ashok Tuteja, MD, MPH
• Phone: 8015821565
• Email: ashok.tuteja[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gulf War Illness

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	George E Wahlen VA Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Ashok Tuteja	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the bowel symptom scale from the baseline	Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks	Baseline to 8 weeks
Secondary	Change in chronic fatigue (1-5 scale) from baseline	Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 4 weeks.	baseline to 4 weeks
Secondary	Change in chronic fatigue (1-5 scale) from baseline	Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 8 weeks.	baseline to 8 weeks