OCEaN
Research type
Research Study
Full title
Optimisation before Crohn's surgery using Exclusive Enteral Nutrition
IRAS ID
325763
Contact name
Rachel Cooney
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Crohn’s disease is a lifelong inflammatory illness that causes people to have severe stomach pains, chronic diarrhoea, and suffer weight loss. There is no cure. Crohn’s disease causes inflammation, ulceration, bleeding and narrowing of the digestive system. People can have periods of good health (“remission”) and times when symptoms are more active (“flare ups” or “relapses”). Medications can help keep it in remission, however one third of people will need surgery to remove/repair part of their diseased gut at some stage.
Previous studies suggest that a special liquid diet might help improve recovery from surgery. This diet is called “exclusive enteral nutrition” (EEN) because it is the only form of food taken for a period of time. In active Crohn’s disease, we know that this special liquid diet can improve symptoms, reduce inflammation and heal the gut better than steroids. EEN is not offered routinely to patients at the moment because we don't have any evidence based research.
This study aims to find out whether 6 weeks of EEN diet pre surgery might help participants recover quicker and make the surgery safer with less chance of complications compared to a usual diet pre surgery. All patients will undergo surgery and be followed up for one-year with information about disease activity, medication use, health-related quality-of-life, health resource usage obtained. If the liquid diet can be shown to improve symptoms, widespread uptake is anticipated.
We will recruit 618 patients from across the UK due to have surgery for Crohn’s disease.
An embedded qualitative study will explore patients and healthcare professionals' views and experiences of all aspects of the trial.
There is an optional sub-study (n=200), COAST, which involves a more detailed assessment of outcomes related to early/late surgery and dietary aspects in terms of nutrient intake, dietary habits and food related quality-of-life.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0513
Date of REC Opinion
9 Jun 2023
REC opinion
Favourable Opinion