Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation Predominant Irritable Bowel Syndrome (C-IBS)

This study is not yet open for participant recruitment.

Verified by Cedars-Sinai Medical Center, July 2009

First Received: July 23, 2009 No Changes Posted

Sponsor:	Cedars-Sinai Medical Center
Collaborator:	Salix Pharmaceuticals
Information provided by:	Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00945334

Purpose

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.

Condition	Intervention
Constipation Predominant Irritable Bowel Syndrome	Drug: Neomycin Drug: Placebo Drug: Rifaximin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Neomycin palmitate Rifaximin Neomycin Neomycin sulfate

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:

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. [ Designated as safety issue: No ]

Estimated Enrollment:	89
Study Start Date:	August 2009

Arms	Assigned Interventions
Group 1 Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days	Drug: Neomycin 500 mg po bid for 14 days Drug: Placebo placebo for 14 days tid
Group 2: Experimental Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days	Drug: Neomycin 500 mg po bid for 14 days Drug: Rifaximin 550 mg po tid

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945334

Contacts

Contact: Kimberly Low, BA

(310)423-3792

kimberly.low@cshs.org

Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Salix Pharmaceuticals

Investigators

Principal Investigator:

Mark Pimentel, MD, FRCP(C)

Cedars-Sinai Medical Center

More Information

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.

Responsible Party:	Cedars-Sinai Medical Center
Study ID Numbers:	18709
Study First Received:	July 23, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00945334 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Intestinal Diseases
Pharmacologic Actions
Protein Synthesis Inhibitors

Anti-Bacterial Agents
Signs and Symptoms
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Syndrome
Irritable Bowel Syndrome
Constipation
Rifaximin
Neomycin
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on February 08, 2010