None listed
Conditions
Brief summary
Following bowel resection due to cancer, up to 80% of patients will experience variable and unpredictable bowel function and symptoms termed as Low Anterior Resection Syndrome (LARS). The exact mechanism of LARS remains unclear and currently there is no standard treatment. Research shows that the gut microbiome, also known as gut bacteria, is changed in patents following bowel cancer and may be linked with LARS and the changes in bowel function and symptoms experienced. This program of research therefore aims to examine the effect of Faecal Microbiota Transplantation in LARS symptoms, the gut microbiome and quality-of-life. Who is it for? You may be eligible for this study if you are aged 19 years or older, have had an ileostomy reversed with a background of low anterior resection or ultra-low anterior resection due to adenocarcinoma of the colon or rectum, and are experiencing symptoms of minor or major LARS. Study details Participants will be randomised (i.e. allocated by chance) to receive one of two different doses of faecal microbiota transplant, or standard care. Faecal microbiota transplant involves administering faecal matter via a syringe using colonoscopy, which requires insertion of a flexible tube into the rectum, and will take an addition of approximately 5 minutes to your routine colonoscopy to complete. Participants allocated to standard care will not receive a faecal microbiota transplant. All participants will answer a number of questionnaires about bowel function and quality of life, and will provide a stool sample for analysis at baseline and week 4 of the study. Participants will also provide a blood sample to assess their immune response and signs of inflammation at baseline and week 4 of study. It is hoped that this research will show that faecal microbiota transplant is an effective treatment for reducing symptoms of LARS and improving quality of life in patients who have undergone a low anterior resection.
Interventions
Following bowel resection due to cancer, up to 80% patients will experience variable and unpredictable bowel function and symptoms termed as Low Anterior Resection Syndrome (LARS). The exact mechanism of LARS remains unclear and currently there is no standard treatment.
This program of research will investigate if Faecal Microbiota Transplantation (FMT) can improve the bowel function and patient’s quality of life (QoL).
Phase 1- Dose-finding-study.
Group 1: FMT at one year post Ultra Low Ant
Following bowel resection due to cancer, up to 80% patients will experience variable and unpredictable bowel function and symptoms termed as Low Anterior Resection Syndrome (LARS). The exact mechanism of LARS remains unclear and currently there is no standard treatment. This program of research will investigate if Faecal Microbiota Transplantation (FMT) can improve the bowel function and patient’s quality of life (QoL). Phase 1- Dose-finding-study. Group 1: FMT at one year post Ultra Low Anterior Resection (ULAR)/LAR via lower route (colonoscopy). Dose includes 4 x BiomeBoostTM FMT syringes, containing a total of 50 g of faecal matter as the active ingredient. Group 2: FMT at one year post ULAR/LAR via lower route (colonoscopy). Dose includes 6 x BiomeBoostTM FMT syringes, containing a total of 75 g of faecal matter as the active ingredient. FMT dose will be administered at one time, by the specialist conducting the colonoscopy (gastroenterologist/surgeon). The procedure of delivering FMT will only add 5 minutes to the routine colonoscopy being performed. Adherence will be monitored by: 1. Dietetic phone follow up "How well did you follow the intervention" in a non judgmental format.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Ileostomy reversed with background of LAR or ULAR due to adenocarcinoma of the colon or rectum ii. Minor or Major Low Anterior Resection Syndrome (LARS) iii. >18 years of age
Exclusion criteria
i. Metastatic colorectal cancer (stage IV) ii. Inflammatory Bowel Disease iii. Patients with dementia iv. Inability to provide informed consent v. Permanent ileostomy/colostomy vi. Planned for post-operative radiotherapy vii. Autoimmune disease (uncontrolled) or on steroids (systemic) i.e. prednisolone viii. Anaphylactic food allergy ix. Neutropenia (<1) x. Pregnant or breast feeding xi. Use of probiotics, once recruited
Outcome results
None listed