Electron micrograph
of C. difficile

Laboratory processing
of faecal samples

C. difficile Colon Infection

Faecal Bacteriotherapy
Market Report
Allogenic Procedure
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Development and Delivery of a Treatment for Clostridium difficile

The problem. Patients treated with broad spectrum antibiotics, pelvic irradiation or immunosuppressive medications are at great risk of contracting Clostridium difficile diarrhoea (CDD). Many of those affected are hospitalized elderly patients with serious underlying illnesses. These treatments can cause disruption of the normal intestinal flora, an important part of the immune system, leading to an overgrowth of C. difficile. Currently, some 2500 patients suffering from chronic CDD have been treated by faecal bacteriotherapy (FB), using donor samples. Although this procedure is reported to be around 92% effective, it is hazardous, in that infection from the donor could be transmitted to the patient and it involves delivery of faecal samples into the duodenum via a nasal probe.

Funding. The North West Regional Development Agency awarded a £64,000 2 year grant to Willana Lifesciences in Manchester to develop methods to prevent and treat nosocomial diarrhoea especially that caused by Clostridium difficile. Grant period June 2009 to February 2011.

The proposed solution. We propose to treat CDD using a modified faecal bacteriotherapy (MFB), employing autologous samples collected from the patients prior to their treatment. The samples will be homogenised with saline and filtered. The filtrate will be freeze-dried, placed in enteric coated capsules and used to treat the patient's CDD. RFID tags will be employed to associate capsules with the patient and assist with sample inventory.

Progress to date. We have demonstrated that freeze drying faecal samples does not markedly reduce their bacterial variety or numbers. Novel plastic containers for processing faecal samples in a more aesthetic way have been produced and an RFID system has been installed at WL.

Further Funding. A further Euro 0.55 million grant has been obtained from the European FP7 Capacities programme (December 2011) to finance a 4 country consortium of 9 participants in the anti- C. difficile project. We are carrying out the following procedures (a) to (d) :- (a) Large scale production of plastic containers for sample processing. (b) Testing MFB on a mammalian model. (c) Producing and maintaining a project website. (d) Designing a large scale comparative clinical trial of MFB.

The expected benefits and outcomes. The outcome should be a safe and inexpensive non-antibiotic medicament to renew a patient's intestinal flora using autologous samples and prevent or treat CDD. Current therapy for CDD is restricted to only two antibiotics and a parallel allogenic based procedure, we are developing, could be employed to treat populations in the event of a pandemic caused by antibiotic resistant CDD.