Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)

University of Nottingham150 enrolled

Overview

Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a third of these suffer from diarrhoea, which severely impairs their quality of life. Previous studies in Nottingham have suggested that some patients with diarrhoea may have an excess of a chemical called serotonin in their gut. Serotonin stimulates secretion and propulsion in the gut and contributes to diarrhoea. We are interested to see whether a drug, Ondansetron, which blocks the effect of serotonin, would improve symptoms in patients with IBS and diarrhoea. We think the drug may work better in people with a specific gene type so your genetic makeup may be of influence and we would like to test this. Because IBS symptoms fluctuate, one way to determine whether Ondansetron is effective is to perform a randomised placebo controlled trial in which neither the patient nor the doctor knows which medication is being taken in each part of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Irritable Bowel Syndrome With Diarrhoea

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * IBS-D patients meeting the Rome III criteria. * Male or female aged 18-75 years * Women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study., (e.g. implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partners) * Patients who are able to give informed consent. Exclusion Criteria: * Women who are pregnant or breastfeeding * Patients that, in the opinion of the investigator, are considered unsuitable. * Patients who have had abdominal surgery which may cause bowel symptoms similar to IBS (Please note, appendicectomy and cholecystectomy is not an exclusion) * Patient unable to stop anti-diarrhoeal drugs * Patients currently participating in another clinical trial or who have been in a trial in the previous three months Since many patients will be on SSRIs or tricyclics antidepressants these will not be an exclusion criteria, provided they have been on medication at least 3 months and that the dose remains unaltered throughout the study.

Locations (2)

University Hospital of South Manchester NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Outcomes

Primary Outcomes

The primary outcome measure is the difference in average stool consistency during the last two week period of Ondansetron compared to placebo treatment.

Time frame: 2 weeks

Secondary Outcomes

1) Proportion of patients preferring ondansetron versus placebo 2) Proportion wanting to continue with ondansetron versus placebo 3) Difference between ondansetron and placebo periods.

Time frame: Duration of study and post-study analysis