NCT04960306

Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection

Fecal Filtrate Versus Conventional Microbiota Transplantation in the Treatment of Multiple Recurrent Clostridioides Difficile Infection (FILTRATE): A Protocol of a Randomized, Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: University of Pecs · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clostridioides difficile infection (CDI) is one of the most common hospital-acquired infectious diseases with a high mortality rate (6-30%). The treatment of CDI, especially the recurrent form of the disease is still considered a challenge. The FILTRATE randomized controlled trial aims to investigate the safety and efficacy of fecal filtrate transplantation in the treatment of recurrent CDI and compare it with conventional fecal microbiota transplantation (FMT).

Detailed description

The treatment of recurrent CDI is still a burden on the healthcare system. FMT is highly effective for the treatment of recurrent CDI, resulting in the resolution of CDI up to 100% of the cases. FMT also has a good short-term safety profile, however long-term events like transfer of multiresistant bacteria and other living microorganism is still a major problem. On the other hand, the fecal filtrate contains only bacterial debris, proteins, and antimicrobial compounds and not intact microorganisms. The FILTRATE trial is a multicenter, two-arm randomized controlled trial, and aims to compare the safety and efficacy of fecal filtrate transplantation to conventional fecal microbiota transplantation (FMT) in the treatment of recurrent CDI. Adult patients with multiple recurrent (\>1) CDIs will be randomized 1:1 to receive either FMT or fecal filtrate transplantation. The transplantation will be carried out using lyophilized capsule on each arm. The primary endpoint of the study will be the clinical resolution of CDI-associated diarrhea 8 weeks after the interventions. Questionnaires will be completed on enrollment and at the time of each follow-up. Adverse events will be recorded and reported to the relevant institutional and national ethics committee. After the intervention, a one-year follow-up is also planned. Blood and stool samples will be collected at baseline and at each follow-up.

Conditions

• Clostridium Difficile Infection
• Recurrent Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	Fecal filtrate transplantation	Patients will receive 5-8 encapsulated lyophilized fecal filtrate transplantations in enterosolvent, size "0" capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules.
BIOLOGICAL	Conventional fecal microbiota transplantation	Patients will receive 5-8 encapsulated lyophilized conventional fecal microbiota transplantations in enterosolvent, size "0" capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2021-07-13
• Last updated: 2023-05-19

Locations

1 site across 1 country: Hungary