Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

San Antonio Military Medical Center

Status and phase: Unknown; Phase 4

Conditions: Small Intestinal Bacterial Overgrowth

Treatments: Drug: Placebo; Drug: Ciprofloxacin; Drug: Metronidazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02458781

398092-1

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients age greater than 18 who have been diagnosed with SIBO after a clinically indicated hydrogen breath test.
• Patients with liver disease or liver cirrhosis will be included, as this particular group is at higher risk for developing SIBO, would potentially benefit from inclusion, and do not require dose adjustments with either study medication.
• Patients on warfarin are not excluded, but INR will be uniformly recommended to be checked within 1 week of therapy initiation, as standard practice through the Coumadin clinic, for the potential effect on INR and increased risk of bleeding while on any antibiotic

Exclusion criteria

• Patient age less than 18
• Hypersensitivity to the antibiotics
• Pregnancy or breast feeding
• Patients who cannot consent for themselves
• End stage renal disease defined as creatinine clearance <30 mL/min or on hemodialysis.
• Patients who have taken antibiotics in the past 30 days
• Laxatives, stool softeners, or bulk fiber in the last 7 days
• Enemas or suppositories in the last 3 daysⱡ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Ciprofloxacin

Active Comparator group

Description:

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.

Treatment:

Drug: Ciprofloxacin

Metronidazole

Active Comparator group

Description:

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.

Treatment:

Drug: Metronidazole