A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection
FMTREAT
Two-arm, Interventional, Prospective, Open-label, Multi-center Trial to Evaluate the Safety & Effectiveness of FMT for Treatment of Adult Patients With Primary or Recurrent CDI, Using a Novel, Standardized Microbiota Transplantation System
1 other identifier
interventional
150
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 18, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 30, 2017
March 1, 2017
11 months
January 18, 2017
March 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Global cure rate at 10 weeks
10 weeks after enrolment
Time to clinical cure
The number of days between enrolment and the resolution of diarrhoea
Through study completion, an average of 18 months
Time to global cure
The number of days between enrolment and the resolution of diarrhoea without relapse
Through study completion, an average of 18 months
Cure rate at 2 weeks
2 weeks after enrolment
Cure rate at 4 weeks
4 weeks after enrolment
Treatment failure rate
Through study completion, an average of 18 months
Recurrence rate 8 weeks after clinical cure
8 weeks after clinical cure
Secondary Outcomes (9)
Number of adverse events (AE)
Through study completion, an average of 18 months
Number of serious adverse events (SAE)
Through study completion, an average of 18 months
Time of hospitalization
Through study completion, an average of 18 months
Days without diarrhoea during study period
Through study completion, an average of 18 months
Patient related quality of life
0, 7, 14 days after enrolment
- +4 more secondary outcomes
Study Arms (3)
Recurrent CDI FMT
EXPERIMENTALNon-randomized group ("R") for treatment of recurrent CDI with FMT
Primary CDI antibiotic
ACTIVE COMPARATORRandomized group ("F" AB) for the treatment of primary CDI with antibiotics (vancomycin or fidaxomicin)
Primary CDI FMT
EXPERIMENTALRandomized group ("F" FMT) for the treatment of primary CDI with FMT
Interventions
Non-randomized group "R": Patients with recurrent CD infection are treated with FMT in this group. Randomized group "F"FMT: patients with initial CD infection who have severe disease or who are at high risk of recurrence or high risk of developing severe disease are treated with FMT.
Randomized group "F"AB: patients with initial CD infection who have severe disease or who are at high risk of recurrence or high risk of developing severe disease are treated with antibiotics (vancomycin per os 125mg four times a day for 10 days) in this group. In case of treatment failure changes in antibiotic regime (e.g. fidaxomicin per os 200mg per two times a day for 10 days) will be allowed in the line with the recommendations of current CDI treatment guidelines(13).
Eligibility Criteria
You may qualify if:
- Group "R":- recurrent CDI;- positive stool toxin test within 72 hours before enrolment
- Group "F":- first (initial) episode of CDI;- enrolled patient falls in at least one of the following categories:high risk of recurrence or high risk of developing severe CDI or severe or life-threatening CDI;- patient requires hospitalization or CDI occurs during a hospital stay;- persisting symptoms despite least 72 hours of adequate antibiotic treatment;-positive stool CD toxin test obtained within 72 hours before screening;- in all cases, primary consideration must be given to the severity and pace of the patient's CDI when deciding whether early use of FMT is appropriate to prevent further clinical deterioration.
You may not qualify if:
- absence of either patient's or its legally authorized representative's informed consent
- inability or unwillingness to comply with protocol requirements
- severe co-morbidities, terminal underlying disease with a life expectancy of less than 90 days
- pregnancy or breastfeeding
- active gastroenteritis caused by microorganisms other than CD
- underlying chronic gastrointestinal disease that causes diarrhoea such as autonomic diabetic neuropathy, short bowel syndrome, faecal incontinence, active inflammatory bowel disease
- alimentary or over-the-counter drog allergy with previous anaphylactic reaction
- absolute contraindication to FMT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sejtterapia Kozpont Kft.lead
- University of Debrecencollaborator
- Kenézy Gyula Korhaz es Rendelointezetcollaborator
- Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhazcollaborator
- Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhazcollaborator
- Bacs-Kiskun Megyei Korhazcollaborator
- UD-Genomed Kft.collaborator
Study Sites (3)
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
Miskolc, B-a-z County, 3525, Hungary
University of Debrecen, Clinical Centre
Debrecen, Hajdu-Bihar Megye, 4032, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Szabocs-Szatmar-Bereg Megye, 4400, Hungary
Related Publications (1)
Minkoff NZ, Aslam S, Medina M, Tanner-Smith EE, Zackular JP, Acra S, Nicholson MR, Imdad A. Fecal microbiota transplantation for the treatment of recurrent Clostridioides difficile (Clostridium difficile). Cochrane Database Syst Rev. 2023 Apr 25;4(4):CD013871. doi: 10.1002/14651858.CD013871.pub2.
PMID: 37096495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gergely G Nagy, M.D., Ph.D.
University of Debrecen
- STUDY DIRECTOR
Zoltan Szilvassy, M.D., D.Sc.
University of Debrecen
- PRINCIPAL INVESTIGATOR
Gyorgy Paragh, M.D., D.Sc.
University of Debrecen
- PRINCIPAL INVESTIGATOR
Istvan Varkonyi, M.D.
Kenezy Gyula Korhaz es Rendelointezet
- PRINCIPAL INVESTIGATOR
Zoltan Fulep, M.D.
Bacs-Kiskun Megyei Korhaz
- PRINCIPAL INVESTIGATOR
Laszlo Szegedi, M.D.
Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhaz
- PRINCIPAL INVESTIGATOR
Tibor Pap, M.D.
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
- PRINCIPAL INVESTIGATOR
Laszlo Nagy, M.D., D.Sc.
UD-Genomed Kft.
- STUDY CHAIR
Eva Rakoczi, M.D.
Kenezy Gyula Korhaz es Rendelointezet
- STUDY CHAIR
Judit Szabo, M.D., Ph.D.
University of Debrecen
- STUDY CHAIR
Maria Papp, M.D., Ph.D.
University of Debrecen
- PRINCIPAL INVESTIGATOR
Peter Vajo
Sejtterapia Kozpont Kft.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2017
First Posted
February 15, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2017
Study Completion
October 1, 2018
Last Updated
March 30, 2017
Record last verified: 2017-03