Probiotic (Visbiome) for Gulf War Illness

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.

Study Overview

• Status: Unknown
• Conditions: Gulf War Illness
• Intervention / Treatment: Drug: Placebo; Drug: Visbiome; Drug: VSL#3

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ashok Tuteja, MD, MPH; Phone Number: 4019 8015821565; Email: ashok.tuteja@va.gov
• Study Contact Backup: Name: Jaya Vijayan, MBBS; Phone Number: 4672 8015821565; Email: jaya.vijayan@va.gov

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • Recruiting
      • George E Wahlen VA Medical Center
      • Contact: Jaya Vijayan, MBBS; Phone Number: 4672 8015821565; Email: jaya.vijayan@va.gov
      • Contact: Ashok Tuteja,, MD, MPH; Phone Number: 4019 801-582-1565; Email: ashok.tuteja@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (not an active drug/ Inactive component) is given to this group	Drug: Placebo; This is a pill with inactive ingredients; Other Names: Placebo/ Sugar pill
Experimental: Visbiome; Visbiome (probiotic mixture) is given to this group.	Drug: Visbiome; This is a probiotic mixture available to randomized study participants, starting with subject 29
Experimental: VSL #3; VSL #3 (probiotic mixture) is given to this group	Drug: VSL#3; This is a probiotic mixture available to the first 28 subjects randomized to the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ashok Tuteja
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ashok Tuteja, MD, MPH, George E Wahlen VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2013
• Primary Completion (Anticipated): May 31, 2018
• Study Completion (Anticipated): May 31, 2018

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; IBS; Probiotics; Gulf War Illness; GWI
• Other Study ID Numbers: IRB_00059006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No