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The Effects of Rifaximin Therapy in Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02009618
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

Brief Summary:
To evaluate the efficacy of Rifaximin therapy started prior to completion of advanced examination procedure (before colonoscopy) of patients pre-diagnosed with irritable bowel syndrome, and implement it into clinical practice.

Condition or disease Intervention/treatment Phase
IBS Drug: Rifaximin Drug: placebo Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Placebo Comparator: Irritable bowel syndrome patients
placebo tablet was given to another group in same doses for 10 days
Drug: placebo
Experimental: Rifaximin

Irritable bowel syndrome patients

Rifaximin is given to patients 200 mg tablets, 3x2/daily, for 10 days

Drug: Rifaximin
Rifaximin tablet is given as 200 mg 3x2/daily, for 10 days.
Other Name: Colidur 200 mg tablets




Primary Outcome Measures :
  1. patients will be evaluated using a symptom severity and treatment efficacy scale after rifaximin therapy [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 18 and 50 years without alarm symptoms, who were examined at the Gastroenterology Clinic, without endoscopic assessment, due to complaints of Irritable Bowel Syndrome, and pre-diagnosed with Irritable Bowel Syndrome according to the Rome III criteria, will be included in the study.

Exclusion Criteria:

  1. are under the age of 18 years,
  2. are allergic to Rifaximin,
  3. are pregnant and lactating,
  4. have documented diseases of the gastrointestinal system (such as gastric and duodenal ulcers, gastric cancer, small intestine and colon cancer, inflammatory bowel disease [Crohn's and Ulcerative Colitis], gastroparesis, chronic intestinal ischemia, etc.),
  5. have (describe) documented diseases of the pancreas, biliary tract, and liver (such as pancreatitis, biliary colic pain associated with gallstones, acute cholecystitis, choledochal stone, hepatitis, hepatobiliary cancers, etc.),
  6. have previously undergone major abdominal surgery,
  7. have a systemic disease (such as collagen tissue disorders, kidney dysfunction, systemic infection, etc.),
  8. have an identified psychiatric disorder,

    and/or

  9. consume alcohol excessively

Information from the National Library of Medicine

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


Locations
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Turkey
Bezmialem Vakıf University, Gastroenterology Clinic
Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Study Director: Hakan Şentürk, Prof Bezmialem Vakıf University, Gastroenterology Clinic

Publications of Results:
Other Publications:
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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT02009618    
Other Study ID Numbers: 27.1.2013 / 1
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by Bezmialem Vakif University:
IBS
Rifaximin
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents