Probiotic (VSL #3) for Gulf War Illness

Gulf War Illness Clinical Trial

Official title:

Probiotics (VSL #3) for Gulf War Illness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02011542
• Other study ID #: W81XWH-10-1-0593
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 2013
• Est. completion date: July 2016

Study information

• Verified date: October 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective is to determine whether VSL #3 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 VSL #3 on IBS symptoms in GW veterans.

Hypothesis: Treatment with VSL #3 compared to placebo will improve global and individual symptoms of IBS

Aim #2 Determine the efficacy VSL #3 in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).

Hypothesis: Treatment with VSL #3 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: Terminated
• Enrollment: 29
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• 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:
• VSL#3
This is a probiotic mixture
• Placebo
This is a pill with inactive ingredients.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the Bowel Symptom Scale (BSS) From Baseline	Efficacy of VSL #3 in Irritable Bowel Syndrome (IBS) related symptoms in Gulf War illness is measured using BSS at 2, 4, 6, 8 wks	8 weeks
Secondary	Change in Chronic Fatigue (1-5 Scale) From Baseline	Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks	8 weeks