Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Antonio Military Medical Center
• Treatments: Anti-Bacterial Agents; Ciprofloxacin; Fluoroquinolones; Metronidazole

Criteria

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