The Effects of Rifaximin Therapy in Irritable Bowel Syndrome
Primary Purpose
IBS
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rifaximin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for IBS focused on measuring IBS, Rifaximin
Eligibility 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:
- are under the age of 18 years,
- are allergic to Rifaximin,
- are pregnant and lactating,
- 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.),
- 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.),
- have previously undergone major abdominal surgery,
- have a systemic disease (such as collagen tissue disorders, kidney dysfunction, systemic infection, etc.),
have an identified psychiatric disorder,
and/or
- consume alcohol excessively
Sites / Locations
- Bezmialem Vakıf University, Gastroenterology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Irritable bowel syndrome patients
Rifaximin
Arm Description
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
Outcomes
Primary Outcome Measures
patients will be evaluated using a symptom severity and treatment efficacy scale after rifaximin therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT02009618
First Posted
November 19, 2013
Last Updated
December 11, 2013
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT02009618
Brief Title
The Effects of Rifaximin Therapy in Irritable Bowel Syndrome
Official Title
The Effects of Rifaximin Therapy in Patients Pre-Diagnosed With Irritable Bowel Syndrome: A Double-Blind, Randomized, Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS
Keywords
IBS, Rifaximin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irritable bowel syndrome patients
Arm Type
Placebo Comparator
Arm Description
placebo tablet was given to another group in same doses for 10 days
Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Irritable bowel syndrome patients
Rifaximin is given to patients 200 mg tablets, 3x2/daily, for 10 days
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Colidur 200 mg tablets
Intervention Description
Rifaximin tablet is given as 200 mg 3x2/daily, for 10 days.
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
patients will be evaluated using a symptom severity and treatment efficacy scale after rifaximin therapy
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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:
are under the age of 18 years,
are allergic to Rifaximin,
are pregnant and lactating,
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.),
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.),
have previously undergone major abdominal surgery,
have a systemic disease (such as collagen tissue disorders, kidney dysfunction, systemic infection, etc.),
have an identified psychiatric disorder,
and/or
consume alcohol excessively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Şentürk, Prof
Organizational Affiliation
Bezmialem Vakıf University, Gastroenterology Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakıf University, Gastroenterology Clinic
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
12016433
Citation
Olden KW. Diagnosis of irritable bowel syndrome. Gastroenterology. 2002 May;122(6):1701-14. doi: 10.1053/gast.2002.33741.
Results Reference
background
PubMed Identifier
15335408
Citation
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.
Results Reference
background
PubMed Identifier
17040359
Citation
Talley NJ. Irritable bowel syndrome. Intern Med J. 2006 Nov;36(11):724-8. doi: 10.1111/j.1445-5994.2006.01217.x.
Results Reference
background
PubMed Identifier
18217406
Citation
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.
Results Reference
background
PubMed Identifier
15862938
Citation
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.
Results Reference
result
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The Effects of Rifaximin Therapy in Irritable Bowel Syndrome
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