Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Constipation-predominant Irritable Bowel Syndrome
• Interventions: Drug: Neomycin; Drug: Placebo; Drug: Rifaximin

• Registration Number: NCT00945334
• Lead Sponsor: Mark Pimentel, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Start: 2009-08
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-02-25
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-17
• Last Update Submitted: 2015-07-17
• Results First Posted: 2015-08-10
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Neomycin	Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Group 1	Placebo	Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Group 1	Neomycin	Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Group 2	Rifaximin	Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Primary Outcome Measures

Name	Time	Method
Severity of Constipation in Each Arm at Week 1 After Completion of Therapy	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

Name	Time	Method
Change in Methane From Baseline	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.

Trial Locations

Locations (2)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Georgia Health Sciences University; 🇺🇸 Augusta, Georgia, United States