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Original study product (VSL #3) became unavailable; change in study Collaborator and product
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (not an active drug/ Inactive component) is given to this group |
|
| VSL #3 | Active Comparator | VSL #3 (probiotic mixture) is given to this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Drug | This is a probiotic mixture |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George E Wahlen VA Medical Center | Salt Lake City | Utah | 84132 | United States |
This study is ongoing; information on enrolled participant arm assignment is blinded, therefore these arms/groups are combined
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| ID | Title | Description |
|---|---|---|
| FG000 | VSL #3 or Placebo | Study participants enrolled into the VSL #3 arm or the Placebo arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | VSL #3 or Placebo | Study participants enrolled into the VSL #3 arm or the Placebo arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | 8 weeks |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VSL #3 or Placebo | Study participants enrolled into the VSL #3 arm or the Placebo arm |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashok Tuteja | University of Utah, Dept. of Gastroenterology | 801-581-5679 | ashok.tuteja@hsc.utah.edu |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Drug |
This is a pill with inactive ingredients. |
|
|
| Sex: Female, Male |
|
|
| 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 | 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. | Posted | 8 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004066 | Digestive System Diseases |