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 ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Salix Pharmaceuticals

Information provided by (Responsible Party):

Mark Pimentel, MD, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT00945334

First received: July 23, 2009

Last updated: April 29, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 23, 2009

Last Updated Date

April 29, 2013

Start Date ^ICMJE

August 2009

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00945334 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Double-blind, Placebo Controlled Trial Comparing Neomycin to Rifaximin Plus Neomycin in the Treatment of Methane Positive Subjects With Constipation-predominant Irritable Bowel Syndrome

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Constipation-predominant Irritable Bowel Syndrome

Intervention ^ICMJE

Drug: Neomycin
500 mg po bid for 14 days
Drug: Placebo
placebo for 14 days tid
Drug: Rifaximin
550 mg po tid

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00945334

Other Study ID Numbers ^ICMJE

18709

Has Data Monitoring Committee

Yes

Responsible Party

Mark Pimentel, MD, Cedars-Sinai Medical Center

Study Sponsor ^ICMJE

Mark Pimentel, MD

Collaborators ^ICMJE

Salix Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Mark Pimentel, MD, FRCP(C)

Cedars-Sinai Medical Center

Information Provided By

Cedars-Sinai Medical Center

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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