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| ID | Type | Description | Link |
|---|---|---|---|
| 22/WM/0222 | Other Identifier | Health Research Authority |
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| Name | Class |
|---|---|
| Lancaster University | OTHER |
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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.
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 'Ensureâ„¢', 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 BENEOâ„¢, 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 Ensureâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Stoma feeding |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 Ensureâ„¢ (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Microbiota | 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. | 1 month |
| Concentration of Immune Cell Populations | Immune cell populations will be identified and profiled using flow cytometric analysis and/or immunohistochemistry. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay in hospital | 1 month |
| Rate of clinical complications | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kina Bennett | Contact | (+44) 01772 522031 | kina.bennett@lthtr.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Kina Bennett | Lancashire Teaching Hospitals NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancashire Teaching Hospitals NHS | Recruiting | Preston | Lancashire | PR2 9HT | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2023 | Feb 23, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Cohort
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| 1 month |