The Effects of Rifaximin Therapy in Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT02009618|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|IBS||Drug: Rifaximin Drug: placebo||Not Applicable|
Irritable Bowel Syndrome(IBS) is a chronic relapsing disorder with unknown etiology characterized by abdominal pain and bowel habit changes without an organic pathology. Pathophysiology is not fully understood, bacterial overgrowth is one of the reasons. Because of that, use of drugs effective on the gut flora has been raised; Rifaximin is one of them. This study investigated the effectiveness of Rifaximin on IBS.
This randomized, double-blinded, controlled study began with 500 patients(144 of them removed because of incompliance). Patients those without organic bowel pathology and whom meet the Rome-III criteria, aged between 19-50 yo were enrolled in the study. Patients with known Rifaximin allergy, lactose intolerance, and those having treated for IBS whit in last 1 month as well as those with alarm symptoms (melena, fever, weight loss, anemia, rectal bleeding) were excluded. After routine biochemistry, blood count, and stool tests, Rifaximin tablet was given to a group as 1200 mg. daily in 3 divided doses, placebo tablet was given to another group in same doses for 10 days. Improvement in symptoms were scored and recorded on 10.day, 3. and 6.week. In addition to descriptive statistical methods(mean±SD), Student's-T and Mann-Whitney U-tests were used for comparison of quantitative data, chi-square and McNemar tests were used for comparison of qualitative data. Significance was accepted if p <0.05.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Effects of Rifaximin Therapy in Patients Pre-Diagnosed With Irritable Bowel Syndrome: A Double-Blind, Randomized, Placebo Controlled Study|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Placebo Comparator: Irritable bowel syndrome patients
placebo tablet was given to another group in same doses for 10 days
Irritable bowel syndrome patients
Rifaximin is given to patients 200 mg tablets, 3x2/daily, for 10 days
Rifaximin tablet is given as 200 mg 3x2/daily, for 10 days.
Other Name: Colidur 200 mg tablets
- patients will be evaluated using a symptom severity and treatment efficacy scale after rifaximin therapy [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009618
|Bezmialem Vakıf University, Gastroenterology Clinic|
|Istanbul, Turkey, 34093|
|Study Director:||Hakan Şentürk, Prof||Bezmialem Vakıf University, Gastroenterology Clinic|