Clostridium Difficile Infection Clinical Trial
Official title:
Fecal Filtrate Versus Conventional Microbiota Transplantation in the Treatment of Multiple Recurrent Clostridioides Difficile Infection (FILTRATE): A Protocol of a Randomized, Controlled Trial
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).
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02214771 -
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients
|
N/A | |
| Withdrawn |
NCT01552668 -
Fidaxomicin to Prevent Clostridium Difficile Colonization
|
Phase 4 | |
| Recruiting |
NCT03325855 -
Fecal Microbiota Transplant National Registry
|
||
| Not yet recruiting |
NCT03586206 -
Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
|
||
| Recruiting |
NCT03350711 -
A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
|
||
| Withdrawn |
NCT03643887 -
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
|
Phase 2 | |
| Terminated |
NCT04000555 -
Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
|
Phase 4 | |
| Terminated |
NCT03065374 -
Treatment for Clostridium-difficile Infection With IMM529
|
Phase 1/Phase 2 | |
| Completed |
NCT03710694 -
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
|
N/A | |
| Completed |
NCT02865616 -
MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI)
|
Phase 1 | |
| Recruiting |
NCT04940468 -
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
|
N/A | |
| Completed |
NCT02589847 -
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
|
Phase 2 | |
| Not yet recruiting |
NCT01942447 -
Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
|
N/A | |
| Active, not recruiting |
NCT02086916 -
Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection
|
N/A | |
| Completed |
NCT01230957 -
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
|
Phase 2 | |
| Completed |
NCT01241552 -
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
|
Phase 3 | |
| Not yet recruiting |
NCT04567134 -
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
|
||
| Completed |
NCT04075422 -
Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
|
||
| Recruiting |
NCT03712722 -
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
|
||
| Recruiting |
NCT05192148 -
Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile
|
N/A |