Does feeding the bowel prior to surgery improve outcomes?
Research type
Research Study
Full title
Does stoma feeding improve the microflora in the distal limb of loop ileostomy patients and is this linked to a reduction in post-operative complications?
IRAS ID
315656
Contact name
Rachael Rigby
Contact email
Sponsor organisation
Lancashire Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Surgical formation of a loop ileostomy to divert the faecal stream and allow tissue healing, with the aim of re-joining the bowel around 1 year later, is carried out in around 9000 patient per year in the UK. One in 4 patients experience severe side effects, such as inflammation or lack of function following reversal, and 5% of patients cannot undergo reversal, leaving them with a permanent stoma. Our data shows that patients that have greater reduction in their microflora are more likely to experience side effects. Therefore we would like to investigate ways of replenishing the microflora prior to surgery.
A small number of patients receive 'stoma’ or ‘enteral’ feeding into the defunctioned bowel, prior to loop illeostomy reversal surgery to improve the bowel condition. Enteral feeding is limited to ‘high risk’ patients, usually those with inflammatory bowel disease or short bowel. We propose to conduct a pilot study to assess whether enteral feeding in these ‘high risk’ patients alters the microflora, prior to applying to complete a randomised, controlled trial to assess the effectiveness of enteral feeding in standard-care patients.
The enteral feeding is carried out through a feeding tube into the defunctioned part of the stoma. Initially patients receive saline and build up to approximately 100ml of ‘Ensure™’, a nutrition shake containing 9 amino acids and various vitamins and minerals, over a period of approximately 4 weeks. We propose to add a source of fibre to the shake, a Chicory root extract made by BENEO™, for the final week to 10 days of stoma feeding. There is evidence to support that oral consumption, in both adult and paediatric patients, of the chicory root extract supports positive microflora growth.
We propose to supplement Ensure™ with up to 10g of chicory root extract for the final 7-10 days of stoma feeding and assess the changes on both the microbiota and on the histological and biomolecular properties of the intestinal tissues. Our biomolecular analysis will include assessment of growth and inflammation markers. We will also record surgical outcomes such as incidence of complications such as ileus, anastomotic leak and chronic bloating/distention.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0222
Date of REC Opinion
27 Oct 2022
REC opinion
Further Information Favourable Opinion