Probiotic (Visbiome) for Gulf War Illness
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|ClinicalTrials.gov Identifier: NCT03078530|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : December 13, 2017
The overall objective is to determine whether Visbiome will improve
- intestinal symptoms of Irritable Bowel Syndrome (IBS) and
- 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 or disease||Intervention/treatment||Phase|
|Gulf War Illness||Drug: Placebo Drug: Visbiome Drug: VSL#3||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Probiotic (Visbiome) for Gulf War Illness|
|Actual Study Start Date :||September 13, 2013|
|Estimated Primary Completion Date :||May 31, 2018|
|Estimated Study Completion Date :||May 31, 2018|
Placebo Comparator: Placebo
Placebo (not an active drug/ Inactive component) is given to this group
This is a pill with inactive ingredients
Other Name: Placebo/ Sugar pill
Visbiome (probiotic mixture) is given to this group.
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
This is a probiotic mixture available to the first 28 subjects randomized to the study
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078530
|Contact: Ashok Tuteja, MD, MPH||8015821565 ext firstname.lastname@example.org|
|Contact: Jaya Vijayan, MBBS||8015821565 ext email@example.com|
|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 firstname.lastname@example.org|
|Contact: Jaya Vijayan, MBBS 8015821565 ext 4672 email@example.com|
|Principal Investigator:||Ashok Tuteja, MD, MPH||George E Wahlen VA Medical Center|