None listed
Conditions
Brief summary
This study aims to test faecal transplant as a potential new therapy for active ulcerative colitis. Patients with ulcerative colitis have a restricted diversity of bacteria in the bowel and faecal transplant aims to replenish the diversiy of the bowel bacteria. Faecal transplant involves the delivery of stool from a faecal donor into the bowel of a patient with the aim of improving symptoms and reducing mucosal inflammation.
Interventions
Faecal transplantation. Pre screened donor faeces will be administered to the right side of the colon via colonoscopy once followed by 2 enemas of donor faeces in the following week. The colonoscopy will usually take between 15 to 30 minutes and the enema less than 5 minutes.
Colonoscopy requires drinking bowel preparation the afternoon prior to the procedure to remove faeces from the colon. The colonoscope is a long tube with a camera on the end, that is inserted into the colon, usually under
Faecal transplantation. Pre screened donor faeces will be administered to the right side of the colon via colonoscopy once followed by 2 enemas of donor faeces in the following week. The colonoscopy will usually take between 15 to 30 minutes and the enema less than 5 minutes. Colonoscopy requires drinking bowel preparation the afternoon prior to the procedure to remove faeces from the colon. The colonoscope is a long tube with a camera on the end, that is inserted into the colon, usually under sedation. The faecal transplant is delivered down the colonoscope and into the bowel. This part of the procedure takes less than 1 minute. The enema is delivered by placing a short introducer into the rectum and delivering 150mls of fluid. This does not require bowel preparation or an anaesthetic.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Mild to moderate active ulcerative colitis (total Mayo score 2 to 10) 2. Endoscopic subscore of 2 or greater (to ensure symptoms are due to UC (not post-inflammatory IBS) 3. Adult patients (aged greater than 18 years)
Exclusion criteria
1. Severe ulcerative colitis (Mayo score 11-12 or Truelove and Witts criteria) 2. More than 25mg of prednisolone per day (or equivalent steroid) 3. Previous colonic surgery 4. Active gastrointestinal infection 5.Pregnancy 6. Anticoagulant therapy or duel antiplatelet therapy (i.e. aspirin and clopidogrel) 7. Current use of antibiotics 8. Anti-TNF therapy
Outcome results
None listed