Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome (C-IBS)

This study has been completed.
Salix Pharmaceuticals
Information provided by (Responsible Party):
Mark Pimentel, MD, Cedars-Sinai Medical Center Identifier:
First received: July 23, 2009
Last updated: July 17, 2015
Last verified: July 2015

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:
  • Severity of Constipation in Each Arm at Week 1 After Completion of Therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Visual analog scale (VAS) score for constipation:

    Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms).

Secondary Outcome Measures:
  • Change in Methane From Baseline [ Time Frame: Baseline (Day 0) and Final Visit (Day 44) ] [ Designated as safety issue: No ]

    Methane output was reported as methane in parts per million (ppm) on breath test:

    Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration.

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
Other Names:
  • Mycifradin
  • Neo-Tab
  • Neo-Fradin
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
Other Names:
  • Mycifradin
  • Neo-Tab
  • Neo-Fradin
Drug: Rifaximin
550 mg po tid
Other Name: Xifaxan


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

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
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Please refer to this study by its identifier: NCT00945334

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
Principal Investigator: Mark Pimentel, MD, FRCP(C) Cedars-Sinai Medical Center
  More Information

Responsible Party: Mark Pimentel, MD, Director, GI Motility Program, Cedars-Sinai Medical Center Identifier: NCT00945334     History of Changes
Other Study ID Numbers: 18709
Study First Received: July 23, 2009
Results First Received: February 25, 2015
Last Updated: July 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cedars-Sinai Medical Center:
Constipation predominant Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses processed this record on October 06, 2015