Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288464
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-09
Brief Title:
Enteral Feeding of Fibre to Improve Microbiota
Sponsor:
Lancashire Teaching Hospitals NHS Foundation Trust
Organization:
Lancashire Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Does Distal Enteral Feeding of Fibre Positively Affect the Microflora in the Distal Limb of Loop Ileostomy Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 22WM0222 | OTHER | Health Research Authority | None |