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

Constipation-predominant Irritable Bowel Syndrome Clinical Trial

— C-IBS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945334
• Other study ID #: 18709
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: July 17, 2015
• Start date: August 2009
• Est. completion date: June 2013

Study information

• Verified date: July 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Constipation-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Neomycin
500 mg po bid for 14 days
• Placebo
placebo for 14 days tid
• Rifaximin
550 mg po tid

Locations

Country	Name	City	State
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Mark Pimentel, MD	Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2006 Jul 11. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No