Microbiome Treatment Centre

Our centre brings together clinicians and scientists in microbiology and gastroenterology who are experts in FMT and colleagues with extensive experience of GMP production of biological therapies.

Faecal microbiota transplant (FMT) is the transfer of the gut bacteria and other components in faeces from a screened healthy donor to an individual with a specific disease with the aim of treating the disease.

FMT can be administered either through the upper gastrointestinal tract by a tube placed from the nose into the stomach or small bowel or via the lower bowel (by colonoscopy or as a rectal enema).

FMT produced by the Microbiome Treatment Centre is produced under Good Manufacturing Practice conditions and stored for up to 6 months in a -80°C freezer.

Throughout the UK, FMT is only currently recommended for the treatment of recurrent and refractory Clostridiodes difficile infection as per the National Institute for Health and Care Excellence guidelines and recommendations through the national guidelines governing the use of FMT as a treatment.¹ However, FMT is under investigation as a therapeutic option to treat other diseases (such as inflammatory bowel disease and complications of liver disease) as part of clinical trials.

Clostridiodes difficile infection

Clostridiodes difficile infection (CDI) is one of the commonest causes of hospital acquired infective diarrhoea in the Western world.²  CDI results from an overgrowth of Clostridiodes difficile leading to toxin production in the gut. This disruption in gut flora is usually due to antibiotic use.

Antibiotics such as metronidazole and vancomycin are very effective in treating initial CDI however, 10% - 20% of patients do not fully respond to antibiotic therapy and suffer recurrence of the infection. The recurrence of CDI is associated with significant morbidity and mortality. FMT has been shown to be highly effective in treating such cases and multiple clinical trials and meta-analysis have demonstrated cure rates of 92% (95% confidence intervals: 89% to 94%).³ Most patients respond to a single infusion of FMT however, repeated infusions can be given for initial non-responders. FMT for CDI is effective regardless of the route of administration and this effectiveness does not appear to change if FMT is frozen for up to 6 months prior to administration. FMT for the treatment of recurrent and refractory CDI is now part of national guidelines and local hospital policies.⁴

As of 1 December 2022 the cost of each 50ml aliquot of FMT is £1300 (VAT exempt) chargeable to the requesting to the site.

Inflammatory Bowel Disease (Ulcerative Colitis / Crohn's Disease)

There is increasing evidence that FMT may be effective for the treatment of active ulcerative colitis (UC). A recent Cochrane review of the four clinical trials conducted so far revealed that 37% of participants in the FMT group reached clinical remission compared to 18% in the control group.⁵ However, due to the significant discrepancies between these studies based upon study design (eg: route of administration of FMT, number of infusions given, patient selection) it the overall efficacy and optimum methodology for FMT administration remains unclear.⁶ Consequently FMT is not currently recommended as a standard treatment option for active UC.

The MTC is collaborating with the largest clinical trial being conducted in the world to date, to determine the effectiveness of FMT for the treatment of active UC: ‘STOP-Colitis’. A Randomised Controlled Trial for the treatment of active UC.

Other conditions

The use of FMT is currently being explored for a whole host of other conditions in clinical trials around the world. Some small-scale studies have been published on the use of FMT for treating complications of liver disease such as hepatic encephalopathy and alcoholic hepatitis, non-alcoholic fatty liver disease, refractory immune checkpoint inhibitor associated colitis and antimicrobial resistance.^7,8 These studies are very early phase and have only provided us a signal towards its efficacy in these diseases. Although, FMT is not yet recommended as a standard of care for treatment of any condition other than CDI, there are over 100 registered clinical trials around the world exploring FMT for various medical conditions. Over the coming years, through clinical trials and evidence based practice it is extremely likely the FMT will be indicated for the treatment of many more conditions.

National Guidelines

We, along with other leading experts in the field of microbiology and gastroenterology from the UK, published national guidelines in July 2018 for the use of FMT to treat diseases. These evidence based guidelines are comprehensive and include indications for the use of FMT, donor screening, preparation of FMT, mode of administration, follow up of patients and current UK regulations. The guidelines are published in Gut and Journal of Hospital Infection. They are open access and therefore freely available to read:

BMJ  Journals : The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridiodes difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines.

Journal of Hospital Infection : The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridiodes difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines.

Under our MHRA “Specials” Licence, we are able to supply FMT for the treatment of recurrent and refractory Clostridiodes difficile infection (CDI) on a named patient basis.

Not only is our request process robust, we have endeavoured to make it as user friendly as possible for all our requesting clinicians. As we are committed to patient safety we have devised a clinical protocol for your guidance on how best to administer our FMT, this is to be used in conjunction with your local guidelines policies.

A patient information leaflet is also supplied for your convenience which intends to educate patients on the use of FMT as a treatment for Clostridiodes difficile infection.

Consultant clinicians who wish to procure a FMT to treat a patient with recurrent or refractory Clostridiodes difficile infection can contact us at bhs-tr.FMT@nhs.net or on 0121 414 4547. A member of the team will supply you with an electronic FMT request form, order form, patient information leaflet and a copy of our clinical protocol in conjunction with our terms and conditions of supply.

In order to process your requests promptly we require both the completed request and order form to be sent back to us via the secure NHS.net inbox (bhs-tr.FMT@nhs.net).

Each request is assessed for its clinical indication by a qualified member of the MTC, and we will liaise with the requesting clinician/team to provide the FMT for when required.  

As of 1 December 2022 the cost of each 50ml aliquot of FMT is £1300 (VAT exempt) chargeable to the requesting to the site.

STOP-Colitis

The STOP-Colitis trial was designed as a prospective multicentre randomised controlled trial run to explore the effectiveness of FMT in the treatment of active Ulcerative Colitis (ISRCTN74072945). The pilot study was conducted at three sites: Birmingham, Glasgow and London and the trial office is based at the Birmingham Clinical Trials Unit (BCTU). As part of the pilot study advanced biological studies around both microbial and host response to FMT in collaboration with academic centres in UK was conducted in order to understand if FMT works in active UC and why it works.If you would like more information on the STOP Colitis pilot study please email STOP-Colitis@trials.bham.ac.uk. Additional information can be found on the Stop Colitis website and the Stop-Colitis twitter page.

At the MTC we produce FMTs using donor stool from healthy individuals. Our donors are screened in accordance with national guidelines.

Donors are recruited following a stringent screening process that involves an extensive medical history and lifestyle assessment and microbiological screening for pathogens in blood and faeces. This screening process ensures that we are producing FMTs of the highest standard.

Our donors are reimbursed for their time, we appreciate the commitment shown by our donors, their participation and involvement throughout the recruitment process and donation period. £100 in vouchers of their choice are issued upon a successful two working week (Monday-Friday) donation period.

If you are interested in finding out more about our Donor Recruitment and Screening program, we would love to hear from you. To register your interest or for further information please email us on microbiometreatmentcentre@contacts.bham.ac.uk.

Frequently asked questions

 

What do you do with donated faeces?

Donated stool samples are mixed with saline and blended to make them smooth and liquid and any large particles are filtered out. The filtered faeces is then stored frozen until it is needed. When a patient requires a faecal transplant, the frozen filtered faeces is defrosted and put into a syringe. The transplant is then put into the patient’s stomach via a tube from their nose or into their colon via colonoscopy or an enema. 

Will I get paid for donation? 

Yes, you will be reimbursed up to a maximum of £200 in a gift card of your choice at the end of a successful 10 day donation period. You are reimbursed to the value of £20 for your time and effort for each day you donate.

What I have to have blood tests?

Yes. A sample of your blood will be required to be tested for blood borne viruses (e.g. hepatitis A and E and syphilis) at the beginning of each donation period. In addition to blood samples you will also be asked to provide faecal samples, a faecal swab, rectal swab and nasopharyngeal swab to screen for enteric and other potentially infectious pathogens.

How will you protect my anonymity?

All your screening tests, samples and donations will be labelled with your unique donor code and never your name. You will have to complete a health questionnaire and to speak to a member of the UoBMTC clinical team about your general health, each time you wish to donate. But this will be kept completely confidential – just like it would be with your own GP. 

What would exclude me from donating? 

You cannot donate if you:

• Are over 50 years of age (you can donate in your 50^th year) or under 18
• Are a current smoker
• Have stools outside the 2-5 types on the Bristol stool scale (https://en.wikipedia.org/wiki/Bristol_stool_scale) 

There are also a range of other diseases, conditions and high-risk activities which could exclude you from donation and these would be assessed by the information given in your completed donor health questionnaire and the initial donor heath check with the UoBMTC clinical team, before any microbiology tests are completed or donations are made. 

What exactly do you mean by “regular morning bowel habits” and why does it matter?

We have a 6 hour window to process the stool donation from when it has been produced. This means you will need to produce a donation and get it to us between 08:00-09:30 on each day of your donation period. 

How long is the donation period?

A donation period is two consecutive weeks: Monday to Friday (10 working days) in which you would be required to make your stool donations. For each donation period you would be required to complete a donor health questionnaire and pass the minimum microbiology screening to permit you to proceed to making stool donations.

Is there a limit to how many times I can donate?

No. Donors are permitted to donate as many times as they wish. In order to donate for another donation period, you would need to complete a new donor health questionnaire and be screened again for the next donation period.

Practically, how would I collect the donation?

You will be provided with wide necked plastic honey jars for you to collect your donations into. They are designed to take a whole stool and most donors find it convenient to pass stool directly into the honey jar. Stool could be passed into an alternative clean container and transferred into the honey jar. 

Does it matter what I eat when I’m donating?

You would be expected to eat your normal diet during the donation period. We would recommend any meat, poultry and fish you eat is cooked fully, and fruit and vegetables washed before eating them.

Eating plenty of fibre and fruit and vegetables and drinking plenty of water during the donation weeks may make regular donation easier. 

What if something unexpected comes up in my screening tests?

If anything unexpected comes up on your screening tests you will be informed about it confidentially by a member of UoBMTC team and will have the opportunity to discuss the result with them.  

How long will my samples and information about my samples be stored?

Retention samples of FMT manufactured from your donations will be stored for 25 years and information regarding your samples will be stored for 30 years. 

What are the benefits of donating?

Faecal microbiota transplantation (FMT) is a novel way of rebuilding healthy gut bacteria intestinal flora and is highly effective in treating a gastrointestinal infection caused by a bacterium called Clostridioides difficile.

The incidence of other gastrointestinal diseases such as ulcerative colitis is increasing. It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of gut bacteria. By donating your stool samples we will be able to further understand through clinical trials and/or treat other gastrointestinal disease that are linked to an imbalance of gut bacteria.

What if I want to stop donating?

You can stop donating at any time with no questions asked. It is entirely voluntary. If you wish to withdraw your consent for donations previously made not to be used, then any FMTs that have not already been administered to patients manufactured from your donations will be destroyed. However, retention samples and data relating to any FMTs manufactured from your donations that have been used to treat patients will be kept for the relevant period.

What if I have any further questions?

Please contact the UoBMTC office, located at:

IBR West Link Level 2.72,
College of Medicine and Health,
University of Birmingham
Edgbaston,
West Midlands,
B15 2TT.
Tel: 0121 414 4547

Our production laboratory is a MHRA regulated facility operating to Good Manufacturing Practice guidelines. It is used exclusively for the production of FMT, and accessible only to authorised personnel.

We have developed stringent processing, decontamination and environmental monitoring procedures to ensure the integrity of our FMTs are uncompromised.

Microbiome Treatment Centre IBR West Link Level 2
College of Medicine and Health
University of Birmingham
Edgbaston
West Midlands
B15 2TT

If you wish to enquire about procuring a FMT, requesting an FMT or simply require some more information please contact us on: 
bhs-tr.FMT@nhs.net 
or +44 (0)121 414 4547

Please note our working hours are 08:00 – 16:00 Monday to Friday.

If you are interested in becoming a donor or would like some further information please email: microbiometreatmentcentre@contacts.bham.ac.uk

At the MTC we are dedicated to not only providing the highest quality of FMTs in line with good manufacturing practice but also understanding its mechanism of action.

Alongside our many collaborators, through clinical research and trials we are continuing to lead the way in understanding the faecal microbiota. 

 

We are also extremely grateful to the voluntary service provided to use by Shropshire, Stafford and Cheshire Blood Bikes. It is with their assistance we are able to deliver FMTs to requesting hospitals so promptly. Their dedication and willingness to help is outstanding. For more information on the great services they provide and their activities please see: https://ssbbgroup.org.uk/contact/

1. Mullish, B. H. et al. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridiodes difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines. Gut 67, 1920–1941 (2018).

2. Public Health England: Clostridiodes difficile: guidance, data and analysis. https://www.gov.uk/government/collections/clostridium-difficile-guidance-data-and-analysis

3. Quraishi, M. N. et al. Systematic review with meta-analysis: the efficacy of faecal microbiota transplantation for the treatment of recurrent and refractory Clostridiodes difficile infection. Aliment. Pharmacol. Ther. 46, 479–493 (2017).

4. Quraishi, M. N. et al. National survey of practice of faecal microbiota transplantation for Clostridiodes difficile infection in the UK. Journal of Hospital Infection 95, 444–445 (2017).

5. Imdad, A. et al. Fecal transplantation for treatment of inflammatory bowel disease. Cochrane Database of Systematic Reviews (2018). doi:10.1002/14651858.CD012774.pub2

6. Quraishi, M. N., Critchlow, T., Bhala, N., Sharma, N. & Iqbal, T. Faecal transplantation for IBD management-pitfalls and promises. Br. Med. Bull. 124, 181–190 (2017).

7. Bajaj, J. S. et al. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology 66, 1727–1738 (2017).

8. Wang, Y. et al. Fecal microbiota transplantation for refractory immune checkpoint inhibitor-associated colitis. Nature Medicine 24, 1804 (2018).