FENDER is an intervention study investigating the effectiveness of taking healthy intestinal bacteria to prevent recurrent intestinal infection with the bacterium Clostridioides difficile.
Aim of the study
Unfortunately, a recurrence of an intestinal infection with Clostridiodes difficile is common despite antibiotic therapy in line with the guidelines.
The ingestion of healthy intestinal bacteria after antibiotic therapy is already being used successfully in patients who have suffered two or more reinfections with Clostridiodes difficile. Recolonization of the intestine with healthy intestinal bacteria prevents the pathogenic bacteria from settling again.
The FENDER study is investigating whether this therapy can also prevent a recurrence of the disease in patients with a first infection or a first recurrence.
Who can take part?
Patients with a first infection or a first recurrence of an intestinal infection with the bacterium Clostridioides difficile.
Procedure
The participants are randomly assigned to an intervention group or a control group. In both groups, patients receive antibiotic therapy for 10 days in line with the guidelines.
In the intervention group, healthy intestinal bacteria are taken in capsules after the antibiotic therapy. Depending on the severity of the infection, it is taken once for two consecutive days (total 2 days) or twice for two consecutive days (total 4 days).
In the control group, no further intake takes place after antibiotic therapy has taken place.
In both groups, three follow-up appointments are then made at the University Hospital Zurich (after 8 weeks, 6 months and 12 months).
Compensation
None
Original study name
Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides difficile Infection First Episode and First Recurrence: A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial (FENDER)
BASEC number
2021-01508
Financial support from