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.
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
|Contact: Ashok Tuteja, MD, MPH||8015821565 ext email@example.com|
|Contact: Jaya Vijayan, MBBS||8015821565 ext firstname.lastname@example.org|
|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 email@example.com|
|Contact: Jaya Vijayan, MBBS 8015821565 ext 4672 firstname.lastname@example.org|
|Principal Investigator:||Ashok Tuteja, MD, MPH||George E Wahlen VA Medical Center|