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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945334
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Mark Pimentel, MD, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Constipation-predominant Irritable Bowel Syndrome Drug: Neomycin Drug: Placebo Drug: Rifaximin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Severity of Constipation in Each Arm at Week 1 After Completion of Therapy [ Time Frame: 1 year ]

    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 :
  1. Change in Methane From Baseline [ Time Frame: Baseline (Day 0) and Final Visit (Day 44) ]

    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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Mark Pimentel, MD, FRCP(C) Cedars-Sinai Medical Center

Responsible Party: Mark Pimentel, MD, Director, GI Motility Program, Cedars-Sinai Medical Center Identifier: NCT00945334     History of Changes
Other Study ID Numbers: 18709
First Posted: July 24, 2009    Key Record Dates
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015
Last Verified: July 2015

Keywords provided by Mark Pimentel, MD, Cedars-Sinai Medical Center:
Constipation predominant Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Protein Synthesis Inhibitors