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 currently recruiting participants.

Verified November 2011 by Cedars-Sinai Medical Center

First Received on July 23, 2009. Last Updated on November 10, 2011 History of Changes

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

Improvement in a mean of the weekly stool diaries for form and frequency of stool. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The success of eradication of methane on breath, improvement in IBS symptoms such as bloating, abdominal pain, sense of incomplete evacuation and gas. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	89
Study Start Date:	August 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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
Experimental: Group 2 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 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

Contacts and Locations

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

Contacts

Contact: Kathleen Shari Chua, BA

(310)423-3792

Chuak@cshs.org

Locations

United States, Arizona
Mayo Clinic Scottsdale	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Michael Lee 480-301-8598 lee.michael4@mayo.edu
Sub-Investigator: John DiBaise, MD
United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Kathleen Shari Chua, BA 310-423-3792 Chuak@cshs.org
Principal Investigator: Mark Pimentel, MD, FRCP(C)

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:	Mark Pimentel, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00945334 History of Changes
Other Study ID Numbers:	18709
Study First Received:	July 23, 2009
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cedars-Sinai Medical Center:

Constipation predominant Irritable Bowel Syndrome

Additional relevant MeSH terms:

Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neomycin

Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012