Recruiting
Phase 2
Phase 3

Visbiome

Sponsor:

Ashok Tuteja

Code:

NCT03078530

Conditions

Gulf War Illness

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Visbiome

VSL#3

Study Details

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.

Conditions

Gulf War Illness

Study ID

NCT03078530

Start date

Sep 13, 2013

Status verified date

Dec, 2017

Completion date

May 31, 2018

Anticipated

Primary completion date

May 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo (not an active drug/ Inactive component) is given to this group

experimental: Visbiome

Visbiome (probiotic mixture) is given to this group.

experimental: VSL #3

VSL #3 (probiotic mixture) is given to this group

Interventions

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

Primary outcome measure

  • Change in the bowel symptom scale from the baseline [ Time Frame: Baseline to 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

George E Wahlen VA Medical Center

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

More Information

Sponsor

Ashok Tuteja

Last update posted

Dec 13, 2017

Last verified

Dec, 2017

Keywords

  • GWI
  • IBS
  • Irritable Bowel Syndrome
  • Gulf War Illness
  • Probiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ashok Tuteja on 2017-12-13.