An interventional study of Soluble Fibre in Bowel Dysfunction, Colon Disease and Ileum--Diseases, sponsored by Lancashire Teaching Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Lancashire Teaching Hospitals NHS Foundation Trust · Not applicable, Interventional, and Supportive care
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 '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.
260 studies on the registry are indexed under Intestinal Diseases; 53 are open to participants now.
This study's planned enrollment of 15 is below the median of 67 across 180 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Lancashire Teaching Hospitals NHS Foundation Trust is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stoma feeding
Dietary Supplement: Soluble Fibre
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.
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.
Time frame: 1 month
Concentration of Immune Cell Populations
Immune cell populations will be identified and profiled using flow cytometric analysis and/or immunohistochemistry.
Time frame: 1 month
Length of Stay
Length of stay in hospital
Time frame: 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.
Time frame: 1 month
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Dec 2025, 34 months after the start.
Of 54 non-industry interventional studies with no phase under Intestinal Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's planned 34 months is above that.
Counting every sponsor, half of 63 studies reached it within 21 months; a quarter within 12 and three quarters within 56.
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Lancashire Teaching Hospitals NHS Foundation Trust