Our body contains trillions of bacteria. Many of these live in our bowel which keeps us healthy and helps our immune system to fight against infections. However, there are an increased number of ‘unfriendly’ bacteria found in the bowel of the patients with liver cirrhosis which makes them highly susceptible to infections. Antibiotics can become ineffective due to frequently prescribed antibiotics and the bowel can become infected with ‘super-bugs’.
Replacing the unfriendly bowel bacteria in patients with cirrhosis with healthy bacteria donated from healthy volunteers (Faecal Microbiota Transplantation) could be highly beneficial and reduce antibiotic usage. Findings from our initial FMT trial (PROFIT Trial) showed that FMT administered during an endoscopy was safe with no serious side-effects. Patients told us however that they would prefer to take tablets rather than have an endoscopy.
We have therefore made a FMT capsule made from freeze-dried stool and in this study, we will test whether treating patients with these FMT capsules will reduce the likelihood of getting an infection.
If you agree to take part in the study, you will be randomly assigned to one of 2 groups. One group (the ‘active treatment’ group) will receive Faecal Microbiota Transplantation (FMT) capsule whilst the other group (the comparison or ‘control group’) will receive a ‘placebo’ treatment. The placebo will be a dummy capsule and will NOT contain any stool.
- You will receive 5 capsules of the medicine (either the FMT or the placebo) to be taken by mouth and swallowed every 91 days for a total of 21 months.
- You will be followed up at different time points - at 30 days from participation, 3 months, 6 months, 1 and 2 years to see how effective the active treatment is based on various measurements taken.
- Your blood, stool and urine samples will also be collected at the time of recruitment, 3 months, 6 months and 1 year.
Our stool comes from healthy vigorously pre-screened donors who are registered as patients at Guy’s and St Thomas NHS Foundation Trust and are between the ages of 18 and 60.
Donors for this study are carefully screened healthy volunteers. They undergo stringent procedures:
a) Tested for a wide range of bacterial and parasitic infections
b) Undergo questionnaire screening for risk factors including bacterial and parasitic infections in accordance with national guidelines published by the British Society of Gastroenterology and the Healthcare Infection Society in the UK
c) With a body mass index between 18-30
d) Each donor will be tested for the presence of Covid-19 with a PCR test.
There are no risks involved in taking part with regard to the samples being obtained, and the amount of blood taken will not be harmful to you. The placebo treatment is not harmful but is not expected to have any benefit on your clinical condition as it contains no active drug or therapy. All patients, regardless of whether they receive placebo or FMT have the same rigorous follow up and support from the trials team. You will be closely monitored after the treatment is given and will be seen at regular intervals afterwards to see if you have experienced any side effects.
This study is being funded by the Efficacy and Mechanism of Evaluation Programme (EME), an NIHR and MRC partnership and jointly sponsored by King’s College London and Kings College Hospital NHS Foundation Trust. The doctor in charge of this study is Professor Debbie Shawcross.
The study protocol and supporting documentation have been reviewed and approved by the funding body, NIHR EME, an independent Research Ethics Committee, who protects the rights and interests of the patients and by the Health Research Authority (HRA). The FMT to be used in this trial has been approved by the Medicines and Healthcare products Regulator Agency (MHRA).
The study will start recruiting patients from March 2022. Recruitment will be carried out for 2-years followed by a follow-up period of 2 years. Each patient will remain on trial for 24 months from the date of treatment or until the 30th of November 2025.
If you have been diagnosed with alcohol-related or fat-related (sometimes referred to as non-alcoholic fatty liver disease or metabolic-related liver disease) cirrhosis at any time point and are aged 18 years and above, you are eligible to take part in the PROMISE trial. Unfortunately, if your cirrhosis is caused by viral hepatitis, autoimmune disease or other causes or you have previously had a liver transplant, you will be ineligible to take part in this study.
If you wish to take part, you will be provided with a Participant Information Leaflet (PIL) by your doctor or an authorised investigator, which would have details of the study. You will have the chance to ask questions and make your decision about taking part freely without pressure. If you are happy to proceed, you will then need to complete a Consent Form confirming your understanding of the study and agreement to take part.
This study will be run at different clinical sites across England, Wales, and Scotland. If you have been seen in any one of the following hospitals, please get in touch with your doctor or clinic for further information.
• Aneurin Bevan University Health Board
• Gateshead Health NHS Foundation Trust
• Glasgow Royal Infirmary
• Imperial College Healthcare NHS Foundation Trust
• King’s College Hospital NHS Foundation Trust (Lead Clinical Site)
• Leeds Teaching Hospitals NHS Foundation Trust
• Newcastle-upon-Tyne NHS Foundation Trust
• Nottingham University Hospitals NHS Trust
• University Hospitals of Derby and Burton NHS Foundation Trust
• Royal Liverpool and Broadgreen Hospitals NHS Trust
• St George’s University Hospitals Trust NHS Foundation Trust
Please visit your General Practitioner (GP) who can send a referral to the participating site in your region.
You have the right to withdraw from the study at any time without giving a reason, and your medical care and legal rights will not be affected.
If you have further questions about the study and how to take part, please contact the PROMISE Team by emailing us at: email@example.com
If you have questions about your health, the treatment being offered and to find out whether you are suitable to take part in the study, please contact your doctor to discuss further.