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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41318

Enrollment

Registered

2013-03-06

Start date

2013-05-30

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carriage of multiresistent bacteria ESBL carriage

Interventions

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 infu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: ESBL carriage demonstrated in stool, rectum, perineum or urine able to give informed consent Life expectancy of three months or more

Exclusion criteria

Exclusion criteria: 1. (Expected) prolonged compromised immunity due to high dose prednisolone, recent cytotoxic chemotherapy for a malignancy, or HIV infection with a CD4 count

Design outcomes

Primary

Measure	Time frame
The outcome and primary study parameter of the study is eradication of ESBL, from feces, urine and rectum. This wil be measured on four days following infusion, and subsequently one, two, four and 12 weeks following donor feces infusion.	—

Secondary

Measure	Time frame
The secondary outcome is antibioc use in the 12 weeks following infusion, the total amount of infections in the follow up period of twelve weeks and the composition of the intestinal flora.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)