Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation Predominant Irritable Bowel Syndrome (C-IBS)
Information source: Cedars-Sinai Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation Predominant Irritable Bowel Syndrome
Intervention: Neomycin (Drug); Placebo (Drug); Rifaximin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Cedars-Sinai Medical Center Official(s) and/or principal investigator(s):
Mark Pimentel, MD, FRCP(C), Principal Investigator, Affiliation: Cedars-Sinai Medical Center
Overall contact:
Kimberly Low, BA, Phone: (310)423-3792, Email: kimberly.low@cshs.org
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 be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in
Scottsdale, AZ.
Clinical Details
Official title: Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Rome III positive IBS subjects (18-75 years of age) -Meet criteria for constipation
predominant IBS symptoms including ≥3 bm 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 Criteria:
- 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
Locations and Contacts
Kimberly Low, BA, Phone: (310)423-3792, Email: kimberly.low@cshs.org
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States
Cedars-Sinai Medical Center, Los Angeles, California 90048, United States
Additional Information
Related publications: Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. Summary for patients in: Ann Intern Med. 2006 Oct 17;145(8):I24. Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y. Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. Epub 2006 Jul 11.
Starting date: August 2009
Last updated: July 23, 2009
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