Ondansetron treatment in IBS-D

• Research type

  Research Study

• Full title

  Ondansetron for the treatment of IBS with diarrhoea (IBS-D): Identifying the "responder".

• Contact name

  Klara Garsed

• Sponsor organisation

  University of Nottingham

• Eudract number

  2008-000623-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  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. Since 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. We think the drug may work better in some people rather than others so we will be making a number of measurements including blood tests to see if we can identify who responds best. The study, will involve the participants with IBS-D visiting the hospital 7 times over a period of 15-16 weeks. After an initial screening period, there will be two separate 5 week treatment periods where the participant receives ondansetron or placebo in each period and records bowel symptoms, separated by a ??wash-out? period when no study treatment is taken. The order in which drug or placebo are taken will be randomised. The study is taking place at the Queen's Medical Centre, Nottingham and Wythenshawe Hospital, Manchester with 150 participants to be recruited in total. The research study is funded by the National Institute of Health Research. Patients wishing to take part can contact Dr Klara Garsed by email klara.garsed@nottingham.ac.uk or telephone 0115 8231038,

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  08/H0408/134

• Date of REC Opinion

  10 Nov 2008

• REC opinion

  Further Information Favourable Opinion