DNTCD

Development of a Novel Treatment for Clostridium Difficile

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 Obiettivo del progetto (Objective)

'We wish to exploit the need for effective treatment for nosocomial diarrhoea especially that caused by Clostridium difficile

disease (CDD). Patients treated with broad spectrum antibiotics are at greatest risk of CDD diarrhoea and many of those

affected are hospitalised elderly patients with serious underlying illnesses. Antibiotics can cause disruption of the normal

intestinal flora, an important part of the immune system, leading to an overgrowth of CDD. Currently, some 2350 patients

suffering from chronic CDD in a number of countries have been treated by faecal bacteriotherapy (FB), using samples

collected from donors. Although this procedure is reported, in a number of small studies, to be around 90% 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.

We propose to treat CDD using a modified FB to restore the patient’s original intestinal flora (employing samples collected

from the patients themselves prior to their treatment) We will produce novel enteric-coated capsules, containing processed

freeze dried colonic flora that can be swallowed by a patient to restore their intestinal flora and immunise them against

further infection by CDD. RFID tags will be employed to associate capsules with the relevant patient and assist with sample

inventory.

3 SMEs in 3 EU states and 5 distinguished research providers along with 1 OTHER SME in the coordination role will collaborate to provide the necessary technology to the project. The coordinator has previously coordinated an EU proposal and acted as a participant in projects over several

Frameworks. The outcome will be a non-antibiotic medicament to treat and prevent CDD The consortium plan to patent the

IPR from the project, exploit and disseminate the technology worldwide and carry out animal and hospital clinical studies.

There are no gender issues related to the proposal but animal and human studies will require ethical approval.'

Introduzione (Teaser)

European researchers are harnessing the action of healthy gut bacteria to combat a type of infectious diarrhoea.

Descrizione progetto (Article)

One in five elderly people undergoing antibiotic therapy in hospitals develop Clostridium difficile disease (CDD). Taking broad-spectrum antibiotics disrupts the gut flora, resulting in CDD and symptoms such as diarrhoea and colitis. When diagnosed promptly, CDD responds well to treatment but recurrence is an issue requiring development of new therapies.

The key objective of the EU-funded 'Development of a novel treatment for clostridium difficile' (http://www.dntcd-project.eu/ (DNTCD)) project is to address such C.difficile nosocomial infections. The idea is to develop a treatment based on faecal bacteriotherapy (FB), using samples collected from donors. A number of studies report the high efficacy of this procedure. This procedure is however associated with certain hazards including the transmission of infections from the donor to the patient.

DNTCD partners propose a modified FB using samples collected from the patients themselves prior to their treatment. These will be freeze-dried and encapsulated in novel enteric capsules for oral intake. The capsules will also contain RFID tags for inventory as well as patient-specific linking.

The DNTCD study will carry out clinical trials to evaluate the safety and efficacy of FB capsules in healthy volunteers and CDD-affected individuals. A database is also underway for the recording and tracking of samples.With recent reports showing a CDD increase among hospitalised children, DNTCD study outcomes could provide an alternative non-antibiotic treatment approach for CDD.