Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461208
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-04
Brief Title:
A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
PROMISE Trial A PROspective Randomised Double-blind Parallel Group Placebo-controlled Multicentre Trial of Faecal MIcrobiota tranSplantation to Improve the Primary outcomE First Hospitalisation Due to Infection in Patients With Cirrhosis Over 24 Months
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief Summary:
A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT versus placebo to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver MASLD cirrhosis
Detailed Description:
There is an evolving crisis of chronic liver disease CLD in the UK and it is the only major chronic disease which is on the rise The advanced stages of CLD known as cirrhosis a hardening and scarring of the liver is the third biggest cause of death and loss of working life years behind heart disease and self-harm People die from cirrhosis young with more than 1 in 10 in their 40s
Patients with cirrhosis are very susceptible to infections antibiotics become ineffective and patients may become infected with super bugs There is an urgent need for antibiotic-free approaches The body contains trillions of microscopic organisms called bacteria which play an important role in keeping us healthy Many of these bacteria live within our bowel and help our immune system fight infection There are increased numbers of unfriendly bowel bacteria in patients with cirrhosis which emit substances that are harmful to health and disrupt the immune system
It could be beneficial to replace the unfriendly bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant known as faecal microbiota transplantation or FMT The PROFIT trial was recently performed as a preliminary trial of FMT which was placed into the bowel with the help of a flexible camera endoscopy The study showed FMT was safe with no serious side effects but patients told us they would prefer to take tablets rather than have an endoscopy The chief investigator and her team have therefore made a capsule which contains dried stool from a healthy donor Participants will need to take 5 of these capsules to achieve the same dose
The PROMISE clinical trial is to test whether treating patients with FMT capsules will reduce the likelihood of them getting an infection by measuring the time it takes to develop an infection resulting in hospital admission This will be compared to a dummy capsule that contains no FMT placebo Patients will be selected at random to have FMT treatment or placebo and both the study team and the patients will not know which treatment they are taking Participants will need to take 5 capsules every 3-months Participants will continue treatment for a total of 21-months or until they develop their first infection leading to hospital admission and will be followed-up for a maximum of 2-years
This study will also examine if having FMT will reduce the side effects of cirrhosis and if it has beneficial effects on the liver and immune system The investigator team will study whether it reduces hospital admissions the incidence of super-bug infections and death Laboratory studies will look at whether FMT treatment will help the immune system fight infection
The World Health Organisation describes the resistance of bacteria to the effects of antibiotics as one of the biggest threats to global health The discovery of new antibiotics has not kept pace The governments white paper proposes a 5-year plan to tackle resistance to antibiotics Consultation with our patient co-applicant patient advisory group The British Liver Trust and Guts UK Charity have highlighted recurrent hospitalisation over-use of antibiotics and fear of acquiring a super-bug as being important priorities to patients The results and study findings will be published in conjunction with patient support groups the wider media and the NHS The investigator will ensure the research impacts on the management of patients with CLD and shapes policy and guideline development
Patients with cirrhosis are very susceptible to infections antibiotics become ineffective and patients may become infected with super bugs There is an urgent need for antibiotic-free approaches The body contains trillions of microscopic organisms called bacteria which play an important role in keeping us healthy Many of these bacteria live within our bowel and help our immune system fight infection There are increased numbers of unfriendly bowel bacteria in patients with cirrhosis which emit substances that are harmful to health and disrupt the immune system
It could be beneficial to replace the unfriendly bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant known as faecal microbiota transplantation or FMT The PROFIT trial was recently performed as a preliminary trial of FMT which was placed into the bowel with the help of a flexible camera endoscopy The study showed FMT was safe with no serious side effects but patients told us they would prefer to take tablets rather than have an endoscopy The chief investigator and her team have therefore made a capsule which contains dried stool from a healthy donor Participants will need to take 5 of these capsules to achieve the same dose
The PROMISE clinical trial is to test whether treating patients with FMT capsules will reduce the likelihood of them getting an infection by measuring the time it takes to develop an infection resulting in hospital admission This will be compared to a dummy capsule that contains no FMT placebo Patients will be selected at random to have FMT treatment or placebo and both the study team and the patients will not know which treatment they are taking Participants will need to take 5 capsules every 3-months Participants will continue treatment for a total of 21-months or until they develop their first infection leading to hospital admission and will be followed-up for a maximum of 2-years
This study will also examine if having FMT will reduce the side effects of cirrhosis and if it has beneficial effects on the liver and immune system The investigator team will study whether it reduces hospital admissions the incidence of super-bug infections and death Laboratory studies will look at whether FMT treatment will help the immune system fight infection
The World Health Organisation describes the resistance of bacteria to the effects of antibiotics as one of the biggest threats to global health The discovery of new antibiotics has not kept pace The governments white paper proposes a 5-year plan to tackle resistance to antibiotics Consultation with our patient co-applicant patient advisory group The British Liver Trust and Guts UK Charity have highlighted recurrent hospitalisation over-use of antibiotics and fear of acquiring a super-bug as being important priorities to patients The results and study findings will be published in conjunction with patient support groups the wider media and the NHS The investigator will ensure the research impacts on the management of patients with CLD and shapes policy and guideline development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN17863382 | REGISTRY | ISRCTN | None |
| 2022-000300-35 | EUDRACT_NUMBER | None | None |
| NIHREME130730 | OTHER_GRANT | None | None |