Overview

TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial

Status:
Unknown status
Trial end date:
2020-02-28
Target enrollment:
0
Participant gender:
All
Summary
A placebo controlled study to determine the efficacy and mode of action of ondansetron in the treatment of irritable bowel syndrome with diarrhoea.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Leeds
Collaborators:
Barnsley Hospital NHS Foundation Trust
Barts & The London NHS Trust
County Durham and Darlington NHS Foundation Trust
Flinders University
London North West Healthcare NHS Trust
Lothian Health Board
Manchester University NHS Foundation Trust
National Institute for Health Research, United Kingdom
NHS Lothian
Queen Mary University of London
Sandwell & West Birmingham Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
University College London Hospitals
University Hospitals of North Midlands NHS Trust
University of Manchester
Treatments:
Ondansetron
Criteria
Inclusion Criteria:

1. Written (signed and dated) informed consent.

2. Considered fit for study participation.

3. Meeting Rome IV criteria for IBS-D

4. Aged ≥ 18 years

5. Undergone standardised workup to exclude the following alternative diagnoses:

1. Microscopic colitis (colonoscopy or flexible sigmoidoscopy),

2. Bile acid diarrhoea (SeHCAT results of > 10% or C4 results of <19 ng/ml), Note:
Cholecystectomy will not be an exclusion criteria if bile acid diarrhoea has been
excluded

3. Lactose malabsorption.

4. Coeliac disease (tTG or duodenal biopsy)

6. All patients must agree to use methods of medically acceptable forms of contraception
during the study and for 90 days after completion of study drug, (e.g. implants,
injectable, combined oral contraceptives, True abstinence (when this is in line with
the preferred and usual lifestyle of the patient) or vasectomised partners)

7. For women of child bearing potential, a negative pregnancy test should be performed
within 72 hours of confirmation of eligibility.

8. Weekly average worst pain score >= 30 on a 0 to 100 point scale.

9. Any stools with a consistency of 6 or 7 on the Bristol Stool Form score (BSFS) for 2
-6 day per week.

Exclusion Criteria:

1. Gastrectomy

2. Intestinal resection

3. Other known organic GI diseases (e.g. Inflammatory bowel disease - Crohns disease,
Ulcerative colitis.)

4. Inability to stop anti-diarrhoeal drugs for the duration of the study.

5. QTc interval >=420msec. Assessed within the last 3 months by a 12-lead ECG.

6. Previous chronic use of Ondansetron or contraindications to it (rare as per BNF)

7. Pulse, Blood pressure, FBC or LFTs outside the normal ranges according to the site's
local definition of normal. Assessed within the last 3 months.

8. Women who are pregnant or breastfeeding

9. Patients currently participating or who have been in an IMP trial in the previous
three months where the use of the IMP may cause issues with the assessment of
causality in this study.

10. Patients taking SSRIs or tricyclic antidepressants are not excluded if on a stable
dose for at least 3 months and with no plan to change the dose during the study.

11. Patients currently taking any of the restricted medications.*

* Restricted medications - Apomorphine, Tramadol & medications likely to alter bowel
habit (in the opinion of the investigator).Caution should be taken with patients on QT
prolonging drugs and cardio toxic drugs. These patients should be reviewed by the PI
to determine if they are suitable for the study.

12. Patients with only stools of consistency 7 on the Bristol Stool Form score (BSFS) for
7 days a week.