NCT02009618

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

November 19, 2013

Last Update Submit

December 11, 2013

Conditions

IBS

Keywords

IBSRifaximin

Outcome Measures

Primary Outcomes (1)

  • patients will be evaluated using a symptom severity and treatment efficacy scale after rifaximin therapy

    3 months

Study Arms (2)

Irritable bowel syndrome patients

PLACEBO COMPARATOR

placebo tablet was given to another group in same doses for 10 days

Drug: placebo

Rifaximin

EXPERIMENTAL

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

Drug: Rifaximin

Interventions

RifaximinDRUG

Rifaximin tablet is given as 200 mg 3x2/daily, for 10 days.

Also known as: Colidur 200 mg tablets
Rifaximin
placeboDRUG
Irritable bowel syndrome patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University, Gastroenterology Clinic

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (5)

  • Olden KW. Diagnosis of irritable bowel syndrome. Gastroenterology. 2002 May;122(6):1701-14. doi: 10.1053/gast.2002.33741.

    PMID: 12016433BACKGROUND

  • 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.

    PMID: 15335408BACKGROUND

  • Talley NJ. Irritable bowel syndrome. Intern Med J. 2006 Nov;36(11):724-8. doi: 10.1111/j.1445-5994.2006.01217.x.

    PMID: 17040359BACKGROUND

  • 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.

    PMID: 18217406BACKGROUND

  • 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.

    PMID: 15862938RESULT

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Hakan Şentürk, Prof

    Bezmialem Vakıf University, Gastroenterology Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

December 12, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

TU(1)