Dietary interventions for the relief of functional gut symptoms in inflammatory bowel disease

King's College London0 sites52 target enrollmentJanuary 21, 2016

Overview

Registry

who.int

Start Date

January 21, 2016

End Date

December 31, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Aged 18 years or over
•2\. Diagnosis of IBD confirmed by standard clinical, histological and radiological criteria for least 6 months
•3\. Inactive disease state (deemed in remission by physician assessment, with GI symptoms that have been assessed with objective investigations and thought not to be a result of active inflammation, and which do not require escalation of IBD
•medications)
•4\. Stable medications (see exclusion criteria), and no GI surgery in preceding 6 months (also see exclusion criteria).
•5\. Have not experienced an IBD flareup in past 6 months
•6\. Faecal calprotectin \<250µg/g (screening 2\)
•7\. CRP \<10mg/l (blood taken as part of routine outpatient appointment, but results checked during screening 2\)
•8\. Functional symptoms meeting the following Rome III criteria:
•8\.1\. IBS diarrhoea predominant, or IBS alternating subtype

•1\. Any evidence of active disease, defined as:
•1\.1\. Requiring a change in treatment as assessed by the treating physician
•1\.2\. Currently taking steroids
•1\.3\. Patients in whom surgery is thought to be imminent
•2\. Changes in dose to azathioprine, 6mercaptopurine, methotrexate or antiTNFa agents during the preceding 12 weeks, oral 5ASA during the preceding four weeks.
•3\. Constipation predominant symptoms (either meeting criteria for IBSC or functional constipation)
•4\. Recent use of the following treatments: antibiotics or probiotics (or prebiotics) in the preceding eight weeks, NSAIDs
•during the preceding week.
•5\. Pure perianal disease
•6\. Current stoma