Enteral Feeding of Fibre to Improve Microbiota

NCT06288464 | Recruiting DMC

• 2 other identifiers: 31565622/WM/0222
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Dysfunction; Colon Disease; Ileum--Diseases

Outcome Measures

Primary Outcomes (2)

• Concentration of Microbiota

  16S rRNA sequencing and qPCR, comparing de-functioned and functional limbs of the ileostomy. Biomolecular analysis of the tissues, to assess growth and inflammation, using histological techniques to quantify and identify the microbiota.

  1 month

• Concentration of Immune Cell Populations

  Immune cell populations will be identified and profiled using flow cytometric analysis and/or immunohistochemistry.

  1 month

Secondary Outcomes (2)

• Length of Stay

  1 month

• Rate of clinical complications

  1 month

Study Arms (1)

Intervention

EXPERIMENTAL

Stoma feeding

Dietary Supplement: Soluble Fibre

Interventions

Soluble Fibre 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead
• Lancaster University: collaborator

Study Sites (1)

Lancashire Teaching Hospitals NHS

Preston, Lancashire, PR2 9HT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intestinal Diseases; Colonic Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kina Bennett

  Lancashire Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Kina Bennett

CONTACT

(+44) 01772 522031; kina.bennett@lthtr.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 1, 2024
• Study Start: January 9, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)