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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002685-38-GB

Enrollment

120

Registered

2005-05-26

Start date

2005-08-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Interventions

Trade Name: Metronidazole Product Name: Metronidazole Pharmaceutical Form: Tablet INN or Proposed INN: Metronidazole CAS Number: 443-48-1 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026