Gulf War Illness
Conditions
Keywords
Irritable Bowel Syndrome, Gulf War Illness
Brief 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.
Detailed 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.
Interventions
DRUGVSL#3
This is a probiotic mixture
DRUGPlacebo
This is a pill with inactive ingredients.
Sponsors
United States Department of Defense
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the Bowel Symptom Scale (BSS) From Baseline | 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Chronic Fatigue (1-5 Scale) From Baseline | 8 weeks | Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks |
Countries
United States
Participant flow
Pre-assignment details
This study is ongoing; information on enrolled participant arm assignment is blinded, therefore these arms/groups are combined
Participants by arm
| Arm | Count |
|---|---|
| VSL #3 or Placebo Study participants enrolled into the VSL #3 arm or the Placebo arm | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: 8 weeks
Population: Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.
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
Time frame: 8 weeks
Population: Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.