Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome
NCT ID: NCT00945334
Last Updated: 2015-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2009-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days
Neomycin
500 mg po bid for 14 days
Placebo
placebo for 14 days tid
Group 2
Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Neomycin
500 mg po bid for 14 days
Rifaximin
550 mg po tid
Interventions
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Neomycin
500 mg po bid for 14 days
Placebo
placebo for 14 days tid
Rifaximin
550 mg po tid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Mark Pimentel, MD
OTHER
Responsible Party
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Mark Pimentel, MD
Director, GI Motility Program
Principal Investigators
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Mark Pimentel, MD, FRCP(C)
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Georgia Health Sciences University
Augusta, Georgia, United States
Countries
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References
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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.
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.
Other Identifiers
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18709
Identifier Type: -
Identifier Source: org_study_id
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