Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth
Information source: San Antonio Military Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Small Intestinal Bacterial Overgrowth
Intervention: Metronidazole (Drug); Ciprofloxacin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: San Antonio Military Medical Center Official(s) and/or principal investigator(s): Karin S Gilkison, MD, MPH, Principal Investigator, Affiliation: Gastroenterology Fellow
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).
Clinical Details
Official title: Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ciprofloxacin and Metronidazole
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of patients cured of SIBO after treatment with ciprofloxacin versus metronidazole versus placebo.
Secondary outcome: Gastrointestinal symptoms based on questionnaireDisease relapse rate of SIBO after treatment success Time interval between treatment success and recurrence of 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2015
Last updated: May 27, 2015
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