Immunology and microbiology of faecal transplant in pouchitis
Research type
Research Study
Full title
An investigation of the immunological and microbiological effects of faecal transplantation in pouchitis
IRAS ID
144815
Contact name
Ailsa Hart
Contact email
Sponsor organisation
Northwest London Hospitals NHS Trust
Research summary
In ulcerative colitis patient requiring surgery, the colon is removed and a reservoir is formed from a pouch of small intestine, preventing the need for a permanent stoma. Inflammation of the pouch (pouchitis) causes 10-15% of pouch failure. An imbalance of gut bacteria contributes to the inflammation. Antibiotics treatment is effective but patients can become refractory to antibiotics with chronic use. One method to redress the bacteria imbalance is to transplant stools from healthy unrelated donors to pouchitis patients. Our previous study showed that a single nasogastric administration of faecal transplant material caused only minor changes to the gut bacteria and was not able to improve the inflammation.
We aim to study if an increased number of faecal transplants can produce a larger change in gut bacteria and if so, the effect on the inflammation of the pouch. This study will be carried out at St Mark’s Hospital.
Volunteer patients with pouchitis will be invited to participate. Over the course of 2 weeks, participants will receive a single administration of 150ml of processed faecal suspension via nasogastric route and 7 alternate day administrations of 50ml of processed faecal suspension directly into the pouch as an enema. All donors will be screened for blood borne viruses and enteric pathogens.
The participants will be followed up at 4-8 weeks interval over 24 weeks to assess their conditions. Besides clinical assessment, endoscopic investigations with pouch tissue sampling will be carried out together with stool sample collection. The pouch bacteria changes will be assessed in the stools and pouch tissues whilst the immune changes will be analysed using the pouch tissues. Patients who relapse during this 24 weeks will be offered a second course of faecal transplant therapy using stools from a different donor.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0170
Date of REC Opinion
21 May 2014
REC opinion
Further Information Favourable Opinion