Microbiome Treatment Centre

Set up in 2017 at the University of Birmingham within the Advanced Therapies Facility, this service embodies the service started by Professor Peter Hawkey for the treatment of Clostridium difficile infection at PHE Birmingham in 2014. It was the first UK third party Faecal Microbiota Transplant (FMT) service and treated over 200 patients safely. The Microbiome Treatment Centre (MTC) is the first Medicines and Healthcare products Regulatory Agency (MHRA) licensed facility in the UK to provide FMT for clinical trials and for the treatment of patients with recurrent and refractory Clostridium difficile infection (CDI).


Understandably, the production of FMT suitable for human application is highly regulated. Being the first licensed facility to comply with Good Manufacturing Practice we are “leading the way and setting the UK standards for FMT production, and supply”.

At the MTC we are dedicated to providing a regulated, quality assured, and efficient service.

Under the 2019-2020 NHS England Innovation and technology payment Tariff, FMTs supplied to NHS Trusts in England from 1 April 2019 to 31 March 2020 will be supplied free of charge.

The Microbiome Treatment Centre team

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.

MTC Director

Professor Peter M. Hawkey BSc, Phd, DSc, MBBS, MD,FRCPath, FFPath, FRCPI

Professor Peter Hawkey has published over 280 research papers in the 
areas of molecular evolution and epidemiology of antibiotic resistance, Clostridium difficile, tuberculosis and molecular diagnostics for infectious diseases. One current research focus is on the use of Faecal Microbiome Transplant (FMT) for treating severe Clostridium difficile infection. This work has been expanded to encompass the effect of FMT on inflammatory bowel disease and the patient microbiome. 


He is a regular speaker at international conferences and advisory boards on these topic areas. Peter has edited two widely used clinical microbiology post graduate textbook. His research support has come from the Department of Health NIHR, PHE, NERC, Wellcome Trust and the pharmaceutical industry.

For the last 15 years Peter has researched extensively on the subject of antibiotic resistance in South East Asia particularly through collaborative projects with colleagues in China particularly at Chinese University of Hong Kong. He is visiting Professor at Xiangya Hospital, South Central University, Changsha. He is currently involved in shaping UK national policy on nosocomial infection control and antibiotic resistance by chairing and participating in expert groups and committees in the UK and Europe. He was awarded the Garrod Medal from British Society for Antimicrobial Chemotherapy in 2017.

New Project

MTC Co-Director

Professor Tariq Iqbal

Professor Iqbal is a hollow organ gastroenterologist at the University of Birmingham. His clinical practice is largely in IBD and he is lead for FMT in the UK Gut Microbiome for Health Expert Panel. He is a co-author of the recently published national guidelines on FMT for CDIB. 

New Project (1)

MTC Scientific Advisor

Dr Vicki McCune


Dr Vicki McCune is a Consultant Clinical Scientist in Microbiology who,
with Professor Hawkey, developed the first FMT service in Birmingham. She
provides expert knowledge in diagnostic microbiology related to donor screening and supports the MTC team in the development of methods and process for FMT production. 

New Project (2)

MTC Clinical Advisor & Research Fellow

Dr Mohammed Nabil Quraishi

Dr Mohammed Nabil Quraishi is a senior gastroenterology registrar and
research fellow for UoBMTC. He is the fellow for the STOP-Colitis clinical
trial (FMT to treat active UC) and is completing his PhD exploring host immune and microbiota interactions in ulcerative colitis and primary sclerosing cholangitis. He is a member of the British Society of Gastroenterology Gut Microbiota Health Expert Panel and is the co-lead author of the National Guidelines in the use of FMT. You can follow Dr Quraishi on twitter (@nabilquraishi) 

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MTC Service Manager

Miss Sahida Shabir

MTC Production Manager 

Dr Susan Manzoor

What is FMT?

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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.

FMT for the treatment of disease

Throughout the UK, FMT is only currently recommended for the treatment of recurrent and refractory Clostridium 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.

Clostridium difficile infection

Clostridium 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 Clostridium 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

Under the 2019-2020 NHS England Innovation and technology payment Tariff, FMTs supplied to NHS Trusts in England from 1 April 2019 to 31 March 2020 will be supplied free of charge.

Inflammatory Bowel Disease (Ulcerative Colitis / Crohns 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 Clostridium 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 Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines.iStock-962093726 (1)

Accessing FMT for treatment of CDI

Under our MHRA “Specials” Licence, we are able to supply FMT for the treatment of recurrent and refractory Clostridium 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 Clostridium difficile infection.

Consultant clinicians who wish to procure a FMT to treat a patient with recurrent or refractory Clostridium 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.  

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Under the 2019-2020 NHS England Innovation and technology payment Tariff, FMTs supplied to NHS trusts in England from 1 April 2019 to 31st March 2020 will be supplied free of charge.

Current clinical trials

STOP-Colitis

We are conducting one of the largest trials in the world to date to explore effectiveness of FMT in the treatment of ulcerative colitis. The STOP-Colitis trial is a prospective multicentre randomised controlled trial run for the treatment of active UC (ISRCTN74072945). This trial is conducted at three sites: Birmingham, Glasgow and London and the trial office is based at the Birmingham Clinical Trials Unit (BCTU). As part of this trial we will be performing advanced biological studies around both microbial and host response to FMT in collaboration with academic centres in UK. This way we aim to not just understand if FMT works in active UC but also why it works.

If you are interested in taking part in this study or have a patient you would like refer please email: STOP-Colitis@trials.bham.ac.uk. Additional information can be found on the Stop-Colitis twitter page.

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Donor recruitment

iStock-842459892 (1)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

Q. What do you do with donated faeces?
A. Donated faeces samples are mixed with saline and glycerol. They are then blended together and filtered. The product (FMT) resembles a brown liquid of thick consistency. The FMT is then stored frozen until it is needed. When a transplant is required to treat CDI or for a clinical trial, the frozen FMT is packed and sent to the respective hospital or research facility. The transplant is then put into the patient’s upper gastrointestinal tract (stomach or small bowel) via a tube down their nose or into their colon via colonoscopy or an enema.

Q. Will I get paid for donation?
A. Yes, you will receive £100 in a shopping voucher of your choice at the end of a successful 10 day donation period.

Q. What additional tests will I have to undergo?
A. Your blood will be tested for blood borne viruses such as HIV, Hepatitis C and Hepatitis B, it will also be tested for Syphilis. A sample of faeces will also be tested for gut pathogens. A comprehensive list of tests that we do is available from the national guidelines published in July 2018.

Q. How will you protect my anonymity?
A. All your screening tests samples and donations will be labelled with your donor code and never your name. You will have to answer a health questionnaire and to speak to a member of the FMT medical team about your general health, but this will be kept completely confidential – just like it would be with your own GP.

Q. What exactly do you mean by “regular morning bowel habits” and why does it matter?
A. We need the donations to be collected and processed on the same day. This means you will need to produce a donation and get it to the lab before 10:00am each day. Donation is normally done every day for ten consecutive working days (Monday-Friday).

Q. What would exclude me from donating?
A. Before we invite you for a thorough screening process we do a basic initial screen that would exclude potential donors who are:

  • Are over 50 years of age or under 18
  • Are under or overweight (You must have a BMI ≤18.5 and ≥25). You can check your BMI here
  • Are a smoker
  • Have normal stools outside the 2-5 types on the 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 at your initial donor heath check with the FMT medical team before any tests are done or donations are made.

Q. Practically, how would I collect the donation?
A. You will be provided with a wide necked plastic honey jar for each donation. It is designed to take a whole stool and most donors find it convenient to pass stool directly into this pot. Stool could be passed into an alternative clean container and transferred into the honey jar.

Q. Does it matter what I eat when I’m donating?
A. You would be expected to eat your normal diet during the donation period. Eating plenty of fibre and fruit and vegetables, as well as drinking plenty of water during the donation week may make regular donation easier.

Q. What if something unexpected comes up in my screening tests?
A. If anything unexpected comes up on your screening tests you will be informed about it confidentially by a member of FMT medical team and will have the opportunity to discuss the result with them.

Q.How long will my samples and information about my samples be stored?
A. Information regarding your samples will be stored for the 30 years.  

Q. What are the benefits of donating?
A. Faecal microbiota transplantation as a novel way of restoring healthy gut bacteria intestinal flora and is highly effective in treating a gastrointestinal infection caused by a bacterium called Clostridium difficile. Untreated infections are associated with significant morbidity and mortality. It has been shown to cure 9 out 10 patient with this infection when they fail to respond to conventional antibiotic therapy.

We are also exploring the role of FMT in treating ulcerative colitis as part of a large clinical trial (STOP-Colitis). Ulcerative colitis is a chronic gastrointestinal disease, the incidence of which is rapidly increasing in recent years. Patients with this condition suffer from bloody diarrhoea and abdominal pain. It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of gut bacteria. However the efficacy of ulcerative colitis by faecal microbiota transplantation needs to be further explored. By donating your stool samples we will be able to help us understand if modifying gut bacteria can help treat ulcerative colitis.

Q. What if I want to stop donating?
A. You can stop donating at any time with no questions asked. It is entirely voluntary. 

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Our facility

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.

Contact us

Microbiome Treatment Centre IBR West Link Level 2iStock-637945400
College of Medical and Dental Sciences
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

Our collaborators

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. 

University of Birmingham, University Hospitals Birmingham, ITM and BCTU logos

 

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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/

References

1. Mullish, B. H. et al. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium 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: Clostridium 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 Clostridium difficile infection. Aliment. Pharmacol. Ther. 46, 479–493 (2017).

4. Quraishi, M. N. et al. National survey of practice of faecal microbiota transplantation for Clostridium 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).