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临床试验/NCT06288464
NCT06288464招募中不适用

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

Lancashire Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Concentration of Immune Cell Populations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Concentration of Immune Cell Populations

时间窗: 1 month

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

Concentration of Microbiota

时间窗: 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.

次要结局

  • Length of Stay(1 month)
  • Rate of clinical complications(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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