FAME study: Fecal Administration for eradication of Multiresistant ESBL producing bacteria in carriers

In the Netherlands (and the rest of the world), many patient carry ESBL
producing bacteria in their bowel, in their urine or on their skin, following
admission to a hospital. These ESBL producing bacteria are not susceptible for
the routine antibiotics, and can only be treated with a limited arsenal of
(expensive) antibiotics. There are no current techniques or treatment
strategies to treat carriage of ESBL carrying patients. These patients are at
risk to get new infections with their ESBL producing bacteria, and furthermore,
they can infect other patients. PAtients tend to carry ESBL producing bacteria
for a prolonged period of time after discharge from a hospital.
There is a clear benefit if elimination of ESBL producing carriage can be
achieved.

Donor feces infusion, where feces from a healthy screened donor is infused in
the bowel of a patient has been succesfully applied in patients with recurrent
intestinal infections.

The objective of the study is to see whether donor feces infusions can help to
eradicate ESBL in patients who carry ESBL.

open, prospective non randomised trial. Proof of principle concept, without use
of a control group, given de nature of the intervention, the population and the
lack of suitable alternative therapies.

Patients will be prepared with a laxative drink, on the day prior to the donor
feces infusion. On the day of the donor feces infusion, a duodenal tube is
positioned. Subsequently donor feces is infused in the tube, prepared from
feces from a healthy, througly screened donor.

A donor feces infusion can be separated in three procedures,

1 on the day prior to the investigation, a laxative is taken. This carries no
risk, but patients consider this a nuisance because of the diarrea it
generates.
2 Positioning of the tube in the duodenum carries a theoretical risk of
malpositioning of the tube. This is a risk that can be considered extreme rare.
3 Infusing donor feces through a duodenal tube: one risk is vomiting, which we
try to minimize to position the tube in the duodenum (instead of for instance
the stomach), furthermore we try to reduce the risk by excluding patients with
diminshed bowel passage.
The other risk is transmitting and infectious or otherwise contractable disease
by infusing donor feces. We try to minimize the risk by using healthy screened
donors, who first fill in a questionnaire, followed by a thorough screening of
blood and feces (see protocol paragraph 4.1.1 and .6.2)