Clinical trial NCT06288464: Enteral Feeding of Fibre to Improve Microbiota
Official title: Does Distal Enteral Feeding of Fibre Positively Affect the Microflora in the Distal Limb of Loop Ileostomy Patients?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Dysfunction
Colon Disease
Ileum--Diseases
Lead sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Lancaster University
First posted: 2024-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Concentration of Microbiota
timeFrame: 1 month
measure: Concentration of Immune Cell Populations
timeFrame: 1 month
Secondary outcomes:
measure: Length of Stay
timeFrame: 1 month
measure: Rate of clinical complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS
state: Lancashire
Study officials:
affiliation: Lancashire Teaching Hospitals NHS Foundation Trust
name: Kina Bennett
role: STUDY_CHAIR
References: