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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Neomycin; Drug: Placebo; Drug: Rifaximin

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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-Fradin; Neo-Tab; 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-Fradin; Neo-Tab; Drug: Rifaximin; 550 mg po tid; Other Names: Xifaxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Methane From Baseline	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.	Baseline (Day 0) and Final Visit (Day 44)

Collaborators and Investigators

• Sponsor: Mark Pimentel, MD
• Collaborators: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: Mark Pimentel, MD, FRCP(C), Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Pimentel M, Chatterjee S, Chow EJ, Park S, Kong Y. Neomycin improves constipation-predominant irritable bowel syndrome in a fashion that is dependent on the presence of methane gas: subanalysis of a double-blind randomized controlled study. Dig Dis Sci. 2006 Aug;51(8):1297-301. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11.
• Pimentel M, Park S, Mirocha J, Kane SV, Kong Y. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial. Ann Intern Med. 2006 Oct 17;145(8):557-63. doi: 10.7326/0003-4819-145-8-200610170-00004.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Estimate): August 10, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Constipation predominant Irritable Bowel Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Rifaximin; Neomycin
• Other Study ID Numbers: 18709