The Effects of Rifaximin Therapy in Irritable Bowel Syndrome

The Effects of Rifaximin Therapy in Patients Pre-Diagnosed With Irritable Bowel Syndrome: A Double-Blind, Randomized, Placebo Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: IBS
• Intervention / Treatment: Drug: placebo; Drug: Rifaximin

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Bezmialem Vakıf University, Gastroenterology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Colidur 200 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
patients will be evaluated using a symptom severity and treatment efficacy scale after rifaximin therapy	3 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Study Director: Hakan Şentürk, Prof, Bezmialem Vakıf University, Gastroenterology Clinic

Publications and helpful links

General Publications

• Majewski M, McCallum RW. Results of small intestinal bacterial overgrowth testing in irritable bowel syndrome patients: clinical profiles and effects of antibiotic trial. Adv Med Sci. 2007;52:139-42.
• Barbara G, De Giorgio R, Stanghellini V, Cremon C, Salvioli B, Corinaldesi R. New pathophysiological mechanisms in irritable bowel syndrome. Aliment Pharmacol Ther. 2004 Jul;20 Suppl 2:1-9. doi: 10.1111/j.1365-2036.2004.02036.x.
• Olden KW. Diagnosis of irritable bowel syndrome. Gastroenterology. 2002 May;122(6):1701-14. doi: 10.1053/gast.2002.33741.
• Talley NJ. Irritable bowel syndrome. Intern Med J. 2006 Nov;36(11):724-8. doi: 10.1111/j.1445-5994.2006.01217.x.
• Schoenfeld P. Efficacy of current drug therapies in irritable bowel syndrome: what works and does not work. Gastroenterol Clin North Am. 2005 Jun;34(2):319-35, viii. doi: 10.1016/j.gtc.2005.02.002.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: IBS; Rifaximin
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: 27.1.2013 / 1