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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days |
|
| Group 2 | Experimental | Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neomycin | Drug | 500 mg po bid for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Constipation in Each Arm at Week 1 After Completion of Therapy | Visual analog scale (VAS) score for constipation: Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Methane From Baseline | Methane output was reported as methane in parts per million (ppm) on breath test: Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pimentel, MD, FRCP(C) | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Georgia Health Sciences University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17043337 | Background | Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. doi: 10.7326/0003-4819-145-8-200610170-00004. | |
| 16832617 | Background | Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y. Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid |
| FG001 | Group 2 | Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid |
| BG001 | Group 2 | Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Severity of Constipation in Each Arm at Week 1 After Completion of Therapy | Visual analog scale (VAS) score for constipation: Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms). | Posted | Mean | Standard Deviation | units on a scale | 1 year |
|
Immediately
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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 | Group 1 | Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Pimentel | Cedars-Sinai Medical Center | 3104233792 | chuak@cshs.org |
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| ID | Term |
|---|---|
| D009355 | Neomycin |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D012294 | Rifamycins |
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| Placebo | Drug | placebo for 14 days tid |
|
| Rifaximin | Drug | 550 mg po tid |
|
|
| Baseline (Day 0) and Final Visit (Day 44) |
| Augusta |
| Georgia |
| 30912 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Methane From Baseline | Methane output was reported as methane in parts per million (ppm) on breath test: Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration. | Change in breath test methane gas levels: baseline breath test minus final breath test measurement. | Posted | Median | Standard Deviation | parts per million | Baseline (Day 0) and Final Visit (Day 44) |
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Group 2 | Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid | 0 | 15 | 1 | 15 |
| Unwell | General disorders | Non-systematic Assessment |
|
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| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |