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Probiotic (Visbiome) for Gulf War Illness

This study is currently recruiting participants.
Verified December 2017 by Ashok Tuteja, VA Salt Lake City Health Care System
Sponsor:
ClinicalTrials.gov Identifier:
NCT03078530
First Posted: March 13, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ashok Tuteja, VA Salt Lake City Health Care System
  Purpose

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.

Condition Intervention Phase
Gulf War Illness Drug: Placebo Drug: Visbiome Drug: VSL#3 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotic (Visbiome) for Gulf War Illness

Further study details as provided by Ashok Tuteja, VA Salt Lake City Health Care System:

Primary Outcome Measures:
  • Change in the bowel symptom scale from the baseline [ Time Frame: Baseline to 8 weeks ]
    Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks


Secondary Outcome Measures:
  • Change in chronic fatigue (1-5 scale) from baseline [ Time Frame: baseline to 4 weeks ]
    Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 4 weeks.

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


Estimated Enrollment: 60
Actual Study Start Date: September 13, 2013
Estimated Study Completion Date: May 31, 2018
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078530


Contacts
Contact: Ashok Tuteja, MD, MPH 8015821565 ext 4019 ashok.tuteja@va.gov
Contact: Jaya Vijayan, MBBS 8015821565 ext 4672 jaya.vijayan@va.gov

Locations
United States, Utah
George E Wahlen VA Medical Center Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Ashok Tuteja, , MD, MPH    801-582-1565 ext 4019    ashok.tuteja@va.gov   
Contact: Jaya Vijayan, MBBS    8015821565 ext 4672    jaya.vijayan@va.gov   
Sponsors and Collaborators
Ashok Tuteja
United States Department of Defense
Investigators
Principal Investigator: Ashok Tuteja, MD, MPH George E Wahlen VA Medical Center
  More Information

Responsible Party: Ashok Tuteja, Professor Gastroenterology, VA Salt Lake City Health Care System
ClinicalTrials.gov Identifier: NCT03078530     History of Changes
Other Study ID Numbers: IRB_00059006
First Submitted: March 8, 2017
First Posted: March 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ashok Tuteja, VA Salt Lake City Health Care System:
GWI
IBS
Irritable Bowel Syndrome
Gulf War Illness
Probiotics