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

Mark Pimentel, MD

Status: Completed

Conditions: Constipation-predominant Irritable Bowel Syndrome

Treatments: Drug: Rifaximin; Drug: Neomycin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00945334

18709

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups

Group 1

Experimental group

Description:

Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days

Treatment:

Drug: Neomycin

Drug: Placebo

Group 2

Experimental group

Description:

Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days

Treatment:

Drug: Neomycin

Drug: Rifaximin