drugset / Trial / NCT03053505
A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection
Unknown
150 enrolled
Sejtterapia Kozpont Kft.
Bacs-Kiskun Megyei Korhaz · collabKenézy Gyula Korhaz es Rendelointezet · collabMiskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz · collabSzabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhaz · collabUD-Genomed Kft. · collabUniversity of Debrecen · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a two-arm, interventional, prospective, open-label, multi-center clinical trial with randomized and non-randomized study groups to evaluate the safety and effectiveness of faecal microbiota transplantation (FMT) for the treatment of adult patients suffering from primary or recurrent Clostridium difficile infection (CDI), using a novel, standardized microbiota transplantation system.
Timeline
- Start
- 2017-01
- Primary completion
- 2017-12
- Completion
- 2018-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fidaxomicin | Other / unclassified | 200 mg | Oral |
| Comparator | Vancomycin | Other / unclassified | 125 mg | Oral |
| Subject | faecal human microbiota transplant (FMT) | Other / unclassified | — | — |