Status:
COMPLETED
Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome
Lead Sponsor:
Mark Pimentel, MD
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Constipation-predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will...
Eligibility Criteria
Inclusion
- Rome III positive IBS subjects (18-75 years of age)
- Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools.
- Presence of detectable methane on single breath sample (≥ 3ppm).
- If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.
Exclusion
- Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
- Recent antibiotic use (within the last 30 days)
- Subjects with known pelvic floor dysfunction
- Pregnancy
- Creatinine level \> 1.4
- Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
- Subjects with hearing loss and/or tinnitus
- History of bowel obstruction
- History of celiac disease
- History of inflammatory bowel disease
- Cirrhosis
- Diabetes
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00945334
Start Date
August 1 2009
End Date
June 1 2013
Last Update
August 10 2015
Active Locations (2)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Georgia Health Sciences University
Augusta, Georgia, United States, 30912