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NCT Number: NCT06288464

Enteral Feeding of Fibre to Improve Microbiota

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lancashire Teaching Hospitals NHS

Preston, Lancashire, PR2 9HT, United Kingdom

Location status: Recruiting

Location contact

Arnab Bhowmick

PRINCIPAL_INVESTIGATOR

Kina Bennett

CONTACT

[email protected]

(+44) 01772 522031

Research Access

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Concentration of Microbiota

    Time frame: 1 month

    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.

  2. Concentration of Immune Cell Populations

    Time frame: 1 month

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

Secondary outcomes

  1. Length of Stay

    Time frame: 1 month

    Length of stay in hospital

  2. Rate of clinical complications

    Time frame: 1 month

    Clinical observations or complications (e.g. anastomotic leak, ileus, excessive distention/bloating or wound infection) will be recorded.

    Along with information regarding Patient BMI, sex, date of stoma creation, and history of antibiotic usage (name/duration) during the time stoma was in place should also be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Kina Bennett

CONTACT

[email protected]

(+44) 01772 522031

Sponsors and collaborators

Lead sponsor

Lancashire Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Lancaster University

Registry information

Official study title

Does Distal Enteral Feeding of Fibre Positively Affect the Microflora in the Distal Limb of Loop Ileostomy Patients?

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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