Your gut microbiome is a vast community of trillions of bacteria and fungi that inhabit your gastrointestinal tract, and have a major influence on your metabolism, body weight, propensity to illness, immune system, appetite and mood. A diverse and balanced gut microbiome is key to remaining healthy and becomes disrupted in patients with obesity and chronic diseases such as chronic liver disease, inflammatory bowel disease and autoimmune conditions including arthritis. It may also harbour gut bacteria that are resistant to multiple antibiotics resulting in antimicrobial resistance.
A FMT manufacturing unit was set up and licensed by the MHRA in Jan 2018 under the Directorship of Dr Simon Goldenberg enabling the NIHR RfPB funded PROFIT and FERARO trials to receive their Clinical Trial License. The NIHR Guy’s and St Thomas’ BRC continues to support the unit, utilising existing infrastructure which now supply FMT to several key NIHR-funded clinical trials including the FERARO and PROMISE Trials.
Our FMT manufacturing unit holds MHRA Manufacturer’s Authorisation – Investigational Medicinal Products: Authorisation Number: MIA(IMP) 11387. We produce liquid preparation for administration via enteral tube/colonoscopy or enema and lyophilised capsules.
All donors are screened rigorously in accordance with relevant National or International guidelines under GMP conditions and are released by our QP. These products are suitable for use in Clinical Trials for Investigational Medicinal Products (CTIMP).