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Completed

NCT Number: NCT00945334

Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive 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.

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Key information

Conditions

Constipation-predominant Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neomycin

Drug

500 mg po bid for 14 days

Other names: Mycifradin, Neo-Tab, Neo-Fradin

Placebo

Drug

placebo for 14 days tid

Rifaximin

Drug

550 mg po tid

Other names: Xifaxan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mark Pimentel, MD

Other

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study 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

Acronym: C-IBS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2009
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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