Enteral Feeding of Fibre to Improve Microbiota
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLancashire Teaching Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not undergoing ileostomy or colostomy reversal.
Persons who might not adequately understand verbal explanations or written information given in English
Trial design
Design model
Single group
Treatments tested in this trial
Soluble Fibre
Dietary supplementPatients 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 month2
Concentration of Immune Cell Populations
Immune cell populations will be identified and profiled using flow cytometric analysis and/or immunohistochemistry.
Time frame
1 monthSecondary outcomes
1
Length of Stay
Length of stay in hospital
Time frame
1 month2
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 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lancashire Teaching Hospitals NHS Foundation Trust
Lead sponsor
Lancaster University
Collaborator
Source ClinicalTrials.gov