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Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome

Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: Mark Pimentel, MD

Official(s) and/or principal investigator(s):
Mark Pimentel, MD, FRCP(C), Principal Investigator, Affiliation: Cedars-Sinai Medical Center

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 and Dr. Satish Rao in Georgia Regents University in Augusta, GA.

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

Primary outcome: Severity of Constipation in Each Arm at Week 1 After Completion of Therapy

Secondary outcome: Change in Methane From Baseline

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 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 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

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Georgia Health Sciences University, Augusta, Georgia 30912, 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.

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 17, 2015

Page last updated: August 23, 2015

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