Clinical trial NCT00945334: Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation-predominant Irritable Bowel Syndrome
Keywords: Constipation predominant Irritable Bowel Syndrome
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2009-07-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of Constipation in Each Arm at Week 1 After Completion of Therapy
timeFrame: 1 year
Secondary outcomes:
measure: Change in Methane From Baseline
timeFrame: Baseline (Day 0) and Final Visit (Day 44)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Mark Pimentel, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.7326/0003-4819-145-8-200610170-00004.
citation: 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. doi: 10.1007/s10620-006-9104-6. Epub 2006 Jul 11.