Randomised controlled trial of metronidazole and probiotic preparation versus placebo in the treatment of irritable bowel syndrome - Probiotic in IBS

Phase 1

Active, not recruiting

• Conditions: Irritable Bowel Syndrome

• Registration Number: EUCTR2004-002685-38-GB
• Lead Sponsor: Yakult Honsha Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Age over 18.
Clinical diagnosis of IBS fulfilling Rome II criteria (see appendix)
Normal FBC, U&E, LFT, and inflammatory markers within preceding 2 weeks
Appropriate –ve investigations for organic disease. Patients under 45 do not have to undergo endoscopic or radiological bowel investigation. Patients over the age of 45 with developing symptoms must undergo colonoscopy or barium enema (within last 5 years) to exclude cancer, obstruction, or other structural disease.
Ability to give written informed consent agreeing to participation in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy
Breast Feeding
Inability to give informed consent
Inability to comply with trial protocol
Inflammatory bowel disease or other organic disease of the GI tract
Significant co-morbidity likely to compromise the patient’s ability to comply with the study
Inability to withdraw other medications given for treatment of IBS
Use of other investigational drugs or participation in other clinical trial
Alcoholism / Drug abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of metronidazole followed by a probiotic supplement on overall severity of irritable bowel syndrome as measured by a weekly severity score;Secondary Objective: To assess the effect of metronidazole followed by a probiotic supplement on daily symptoms, weekly satisfaction of relief, and quality of life in subjects with irritable bowel syndrome.;Primary end point(s): The primary outcome variable is change in severity of IBS as measured by the weekly irritable bowel severity score (see appendix). Intensity of symptoms are measured using a five point Likert scale (0 – none; 1- a little; 2 – moderate;3 – a lot; 4 – very severe). The scores can then be summed to give a total score ranging from 0 – 24.