NCT02458781

Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ciprofloxacin and Metronidazole

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: San Antonio Military Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Small Intestinal Bacterial Overgrowth

Interventions

Type	Name	Description
DRUG	Metronidazole	Metronidazole 500mg given twice daily for 14 days
DRUG	Ciprofloxacin	Ciprofloxacin 500mg given twice daily for 14 days
DRUG	Placebo	Placebo given twice daily for 14 days

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-01-01
• Completion: 2018-06-01
• First posted: 2015-06-01
• Last updated: 2015-06-01