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

Study Overview
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Brief Summary
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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.

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

Conditions
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Constipation-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Neomycin
* Drug: Placebo
* Drug: Rifaximin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days | Drug: Neomycin<br>* 500 mg po bid for 14 days<br>* Other names: Neo-Fradin;Drug: Placebo<br>* placebo for 14 days tid<br>|
| Experimental: Group 2<br>Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days | Drug: Neomycin<br>* 500 mg po bid for 14 days<br>* Other names: Neo-Fradin;Drug: Rifaximin<br>* 550 mg po tid<br>* Other names: Xifaxan;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation predominant Irritable Bowel Syndrome