Faecal microbiota TRANSplantation in Cirrhotic patiENts for Depression
Research type
Research Study
Full title
TRANSCEND: Faecal microbiota TRANSplantation in Cirrhotic patiENts to improve Depressive symptoms and quality of life
IRAS ID
351282
Contact name
Victoria Kronsten
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
Depression is a leading cause of disability worldwide, and is more common in patients with end-stage liver disease (termed cirrhosis). Depression in cirrhosis affects quality of life, hospital admission rates and survival.
The body creates inflammation to fight infection. However, there is too much
inflammation in cirrhosis. Bacteria (bugs) in our gut, the gut ‘microbiome’, defend the
body against infection. Patients with cirrhosis have more bad than good gut bacteria
(an imbalanced microbiome) and a leaky gut, which allows bacteria into the
bloodstream. This generates more inflammation, which is harmful. Inflammation and an imbalanced gut microbiome are involved in the development of depression. Giving people good bacteria improves mood. Faecal microbiota transplantation (FMT), or a stool (poo) transplant, replaces the bad bowel bacteria in patients with good bacteria donated from healthy volunteers.In the current PROMISE trial (A PROspective double-blind placebo-controlled
multicentre trial of faecal MIcrobiota tranSplantation to improve outcomEs in patients
with cirrhosis) we are assessing whether FMT, made from freeze-dried stool from healthy
volunteers, reduces the likelihood of getting an infection in 300 patients with cirrhosis (caused by alcohol or fatty liver). Participants are allocated randomly to receive either FMT tablets or placebo every 3-months for 2 years.This ancillary study TRANSCEND (Faecal microbiota TRANSplantation in Cirrhotic patiENts to improve Depressive symptoms and quality of life) will involve conducting semi-structured qualitative interviews with a sub-sample of participants enrolled on the PROMISE Trial at King's College Hospital with the aim of holistically understanding the participants’ experience of the trial, and any change in mental health problems and quality of life throughout the trial by examining lived experience, behaviours, emotions and attributions of change.
An estimated 20 participants will be recruited from King's College Hospital, and will undergo a single 60-minute interview at either their 15-month, 18-month, 21-month or 24-month PROMISE follow-up visit. Interviews will be recorded and transcribed.
REC name
West of Scotland REC 3
REC reference
25/WS/0036
Date of REC Opinion
5 Mar 2025
REC opinion
Favourable Opinion