Enteral Feeding of Fibre to Improve Microbiota

NCT ID: NCT06288464

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-12-01

Brief Summary

Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery.

Detailed Description

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 United Kingdom (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. Previous data shows that patients with less bacteria in the distal bowel may be more likely to develop post-operative complications. This study investigates a method of replenishing the microflora prior to surgery. The data also shows that patients with less bacteria in the distal bowel may be more likely to develop post-operative complications.

This study will pilot a clinical trial 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. A source of fibre will be added 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.

This research aims to investigate ways to increase the numbers of friendly bacteria to improve the health of the distal, non-functioning, bowel by adding fibre to the nutritional supplement fed to the distal bowel for around two weeks prior to surgery. The aim is that this will reduce the risk of complications and possibly reduce the recovery time from bowel surgery.

Conditions

Bowel Dysfunction; Colon Disease; Ileum--Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Stoma feeding

Group Type: EXPERIMENTAL

Soluble Fibre

Intervention Type: DIETARY_SUPPLEMENT

Patients will be assigned to stoma feeding by the Colorectal Surgeon, which will be managed by the stoma nurses for the duration, approximately 4 weeks, of feeding. For the final 7-14 days (minimum 7 days) of feeding, 10g of soluble fibre will be added to 100ml of Ensure™ (or equivalent liquid nutrient feed) before instillation into the stoma on a daily basis. The soluble fibre will be provided in 10g portions and should be added to the newly-opened bottle of ensure and shaken to mix well.

Interventions

Soluble Fibre

Patients will be assigned to stoma feeding by the Colorectal Surgeon, which will be managed by the stoma nurses for the duration, approximately 4 weeks, of feeding. For the final 7-14 days (minimum 7 days) of feeding, 10g of soluble fibre will be added to 100ml of Ensure™ (or equivalent liquid nutrient feed) before instillation into the stoma on a daily basis. The soluble fibre will be provided in 10g portions and should be added to the newly-opened bottle of ensure and shaken to mix well.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Any individual that has been identified for distal (stoma) feeding that is able to understand verbal and written English to provide informed consent.
• Participants must be undergoing ileostomy or colostomy reversal surgery.

Exclusion Criteria

• Not undergoing ileostomy or colostomy reversal.
• Persons who might not adequately understand verbal explanations or written information given in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lancaster University

OTHER

Sponsor Role: collaborator

Lancashire Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kina Bennett

Role: STUDY_CHAIR

Lancashire Teaching Hospitals NHS Foundation Trust

Locations

Lancashire Teaching Hospitals NHS

Preston, Lancashire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Kina Bennett

Role: CONTACT

kina.bennett@lthtr.nhs.uk

(+44) 01772 522031

Facility Contacts

Kina Bennett

Role: primary

kina.bennett@lthtr.nhs.uk

(+44) 01772 522031

Research Access

Role: backup

research.access@lthtr.nhs.uk

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

22/WM/0222

Identifier Type: OTHER

Identifier Source: secondary_id

315656

Identifier Type: -

Identifier Source: org_study_id