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

This study has been completed.
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: June 7, 2013
Last verified: June 2013
  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 and Dr. Satish Rao in Georgia Regents University in Augusta, GA.


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:


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 ]

Enrollment: 37
Study Start Date: August 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Mark Pimentel, MD
Salix Pharmaceuticals
Investigators
Principal Investigator: Mark Pimentel, MD, FRCP(C) Cedars-Sinai Medical Center
  More Information

Publications:
Responsible Party: Mark Pimentel, MD, Director, GI Motility Program, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00945334     History of Changes
Other Study ID Numbers: 18709
Study First Received: July 23, 2009
Last Updated: June 7, 2013
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 July 20, 2014