Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

Small Intestinal Bacterial Overgrowth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02458781
• Other study ID #: 398092-1
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 10, 2015
• Last updated: May 27, 2015
• Start date: January 2015
• Est. completion date: June 2018

Study information

• Verified date: May 2015
• Source: San Antonio Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 days?

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Small Intestinal Bacterial Overgrowth

Intervention

Drug:
• Metronidazole
Metronidazole 500mg given twice daily for 14 days
• Ciprofloxacin
Ciprofloxacin 500mg given twice daily for 14 days
• Placebo
Placebo given twice daily for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Military Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.		2 weeks	No
Secondary	Gastrointestinal symptoms based on questionnaire		Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months	No
Secondary	Disease relapse rate of SIBO after treatment success		Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months	No
Secondary	Time interval between treatment success and recurrence of SIBO		Immediately post-treatment (approximately 2 weeks), 30 days, 4 months, and 9 months	No