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This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of ciprofloxacin versus metronidazole versus placebo in eradication of small intestinal bacterial overgrowth (SIBO).
Approximately 180 study subjects with SIBO identified by positive glucose hydrogen breath (GHB) testing who meet inclusive and exclusive criteria will be randomized to receive either ciprofloxacin 500mg by mouth twice daily, metronidazole 500mg by mouth twice daily, or placebo by mouth twice daily. Subjects will complete a baseline symptom questionnaire and be treated for 14 days. Response will be assessed at end of treatment. The Gastrointestinal Symptom Rating Scale (GSRS) and GHB testing will be performed at the end of treatment. Subjects with a negative GHB at the end of treatment are considered as cured, or treatment success. Patients with treatment success will be reassessed for long-term response to treatment or disease recurrence at 30 days, 4 months, and 9 months using GHB. Symptoms will also be re-assessed at the 30 day, 4 month, and 9 month intervals with GSRS-IBS symptom questionnaire done prior to GHB testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo capsule: To be provided by BAMC Pharmacy. It will be made and stored by BAMC pharmacy. The matching placebo will be a gelatin capsule filled with methylcellulose powder only. Patient will take 2 capsules two times a day for 14 days. |
|
| Ciprofloxacin | Active Comparator | Ciprofloxacin 250mg capsule: To be provided by BAMC pharmacy. It will be made and stored by BAMC Pharmacy. Ciprofloxacin 250mg tablet will be encapsulated with a gelatin capsule filled with methylcellulose. Patient will take 2 capsules of Ciprofloxacin 250mg two times a day for 14 days. |
|
| Metronidazole | Active Comparator | Metronidazole 250mg capsule: To be provided by BAMC pharmacy. It will be made and stored by BAMC Pharmacy. Metronidazole 250mg will be encapsulated with a gelatin capsule filled with methylcellulose. Patient will take 2 capsules of metronidazole 250mg two times a day for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Metronidazole 500mg given twice daily for 14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms based on questionnaire | Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months | |
| Disease relapse rate of SIBO after treatment success | Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin S Gilkison, MD, MPH | Gastroenterology Fellow | Principal Investigator |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D002939 | Ciprofloxacin |
| D024841 | Fluoroquinolones |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Ciprofloxacin | Drug | Ciprofloxacin 500mg given twice daily for 14 days |
|
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| Placebo | Drug | Placebo given twice daily for 14 days |
|
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| Time interval between treatment success and recurrence of SIBO | Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002241 | Carbohydrates |