We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945334
First Posted: July 24, 2009
Last Update Posted: August 10, 2015
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.
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Mark Pimentel, MD, Cedars-Sinai Medical Center
  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
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

Resource links provided by NLM:


Further study details as provided by Mark Pimentel, MD, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.



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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Valeant Pharmaceuticals International, Inc.
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
First Submitted: July 23, 2009
First Posted: July 24, 2009
Results First Submitted: February 25, 2015
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:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Rifamycins
Neomycin
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Protein Synthesis Inhibitors