RecruitingNAINTERVENTIONAL

Enteral Feeding of Fibre to Improve Microbiota

After surgery to remove parts of the bowel, some people have a temporary stoma, which diverts waste and allows the rest of the bowel to heal. When the bowel is reconnected later, problems can sometimes arise. This might be linked to changes in the 'friendly' bacteria that live in our gut. Research suggests that the part of the bowel not being used can become weaker, and these good bacteria might reduce, potentially leading to more side effects after the reconnection surgery. This study aims to find out if giving a specific type of fibre through a feeding tube to this unused section of bowel can help restore these friendly bacteria before the reconnecting surgery. This could potentially reduce complications, hopefully making the recovery smoother for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Lancashire Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

09 Jan 2023

Estimated completion

01 Dec 2025

Bowel Dysfunction Colon Disease Ileum--Diseases

What is this study about?

When people have surgery to remove a diseased part of their bowel, they often have a temporary stoma created. This means that bowel contents are diverted out of the body into a bag, giving the rest of the bowel time to heal. Later on, another operation is done to reconnect the bowel.

Sometimes, people can have problems during or after this reconnection surgery. We know that the part of the bowel that's not being used while the stoma is in place can become weaker, and the number of 'friendly' bacteria that live there can go down. These friendly bacteria are really important for keeping our gut healthy and helping with digestion. Studies have shown that if someone has fewer of these good bacteria, they might be more likely to have problems after their surgery.

This study is looking into a way to help restore these friendly bacteria in the unused part of the bowel before the reconnection surgery. We'll be giving a special fibre supplement into the bowel through a feeding tube. The aim is to see if this helps boost the good bacteria, which could potentially lead to fewer complications and a better recovery for patients after their bowel is reconnected.

Key takeaways

This study tries to improve gut health before bowel reconnection surgery.
It uses a fibre supplement delivered through a feeding tube to help 'friendly' gut bacteria.
The goal is to potentially reduce problems after bowel reconnection.
It's a pilot study to find out if this approach works.
Participation involves receiving specific feeding for about 4-5 weeks.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or over. You need to be able to understand information given to you in English, both spoken and written, so you can give your permission to participate.

You must also be scheduled to have surgery to reverse an ileostomy or colostomy, which means your bowel will be reconnected. The treatment being studied is specifically for people whose doctors have decided they would benefit from receiving nutrients or medication through a tube into the part of the bowel that isn't currently being used due to the stoma.

Therefore, if you are not having ileostomy or colostomy reversal surgery, or if you cannot understand the study information in English, you would not be able to participate.

Quick self-check

Are you 18 years old or older?
Can you understand spoken and written English?
Are you scheduled for ileostomy or colostomy reversal surgery?
Has your doctor identified you as needing feeding into the unused part of your bowel?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the special feeding. This involves a feeding tube being used to deliver substances into the part of your bowel that isn't currently active due to your stoma. Initially, you would receive a saline solution, and gradually, over about four weeks, this would build up to a nutritional shake called 'Ensure™'. This shake contains essential nutrients like amino acids, vitamins, and minerals.

For the last week to ten days of this feeding period, a fibre supplement made from chicory root extract will be added to your shake. During the study, we would take samples to check the types of bacteria in your bowel and look at the health of your bowel tissue. The total duration of the feeding and assessment period is approximately four to five weeks.

Potential risks and benefits

There is a potential benefit that by increasing the 'friendly' bacteria in your bowel, this treatment might reduce the risk of complications when your bowel is reconnected. This is a pilot study, meaning we are testing a new approach, so the exact benefits are not yet fully known. There might be some discomfort associated with the feeding tube, and as with any intervention, there's always a small chance of unforeseen side effects, although the products used are generally well-tolerated. Taking part is entirely voluntary, and you have the right to withdraw from the study at any time without explaining why, and this will not affect your future medical care.

Locations (1)

Lancashire Teaching Hospitals NHS
Preston, United Kingdom· Recruiting

Common questions

What is a temporary stoma?

A temporary stoma is an opening made in your tummy during surgery, which diverts waste into a bag outside your body. It allows the rest of your bowel to heal before it's reconnected later.

What are 'friendly' gut bacteria?

These are beneficial microorganisms that naturally live in our gut. They are important for digestion, absorbing nutrients, and keeping our bowel healthy.

What is enteral feeding?

Enteral feeding means delivering nutrients directly into your gut, usually through a small tube. In this study, it's used to put a nutritional shake and fibre into the part of the bowel that isn't currently being used due to the stoma.

What is chicory root extract?

Chicory root extract is a natural fibre from the chicory plant. It's known to help support the growth of good bacteria in the gut.

Will taking part guarantee a better outcome for my surgery?

No, this is a research study to investigate a potential new approach. While we hope it can help, there's no guarantee it will prevent all complications or ensure a better outcome. The aim is to gather more information.

How to find out more

Kina Bennett

kina.bennett@lthtr.nhs.uk (+44) 01772 522031 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.