Clostridium Difficile InfectionFMTREATNCT03053505
A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection
A study testing faecal human microbiota transplant (FMT) and Vancomycin or Fidaxomicin in people with Clostridium Difficile Infection, run by Sejtterapia Kozpont Kft. at 3 sites in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- faecal human microbiota transplant (FMT) and Vancomycin or Fidaxomicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesHungary
- Study dates
- Jan 2017to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites, 3 recruiting
- Recruiting
University of Debrecen, Clinical Centre
Debrecen, Hajdu-Bihar Megye, 4032
Gyorgy Paragh, M.D., D.Sc.
- Recruiting
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz
Miskolc, B-a-z County, 3525
Tibor Pap, M.D.
- Recruiting
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Szabocs-Szatmar-Bereg Megye, 4400
Laszlo Szegedi, M.D.
About this study
Official title: 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
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.
Read the detailed description
Clostridium difficile is an anaerobe, spore-forming bacillus. Infections with its toxin-producing strains are capable of causing CD associated enteral disease ranging in severity from mild diarrhea to fatal fulminant colitis. CD infection(CDI) occurs among patients who have taken antibiotics previously, suggesting that the normal gut flora is capable of preventing CDI. The disease is mainly treated with antibiotics, however, these antibiotics show high therapeutic failure and recurrence rates. There is significant interest in the development of alternative therapeutic strategies. Among the alternative methods only faecal microbiota transplantation (FMT) is gaining acceptance due to its excellent cure rate and low recurrence rate. FMT is a new approach to treating CDI, since no further antibiotics are administered, instead the normal gut flora being restored by administering faecal homogenisate from a healthy donor. Immediate risks of FMT are minimal, its efficacy is excellent,but further data is required about its short and long term safety, its most appropriate timing during the course of CDI and the optimal technical protocol for preparing the fecal homogenisate. In addition, the procedure is also challenging and the intervention itself is unappealing in nature. To address the challenges described above a novel faecal transplantation system has been designed (Burgin-Matic System, BMS), which is suitable for the production of faecal bacterial suspension in a standardized and controlled environment. Using this new approach, a multi-center,prospective,interventional clinical study involving two groups of patients has been designed: 1. In a non-randomized group("R") the safety and efficacy of FMT with the new, automated transplantation system will be assessed on 50 patients suffering from "R"ecurrent CDI. 2. In a randomized group ("F") FMT will be compared with the gold standard vancomycin treatment for 2x50 patients, with their "F"irst episode of CDI, suffering from severe infection or at risk of developing recurrent or severe disease and not responding to at least 72 hours of antibiotic treatment. In the non-randomized group("R"), the safety and efficacy of FMT will be assessed,with the hypothesis that FMT with the BMS is equally safe and effective(non-inferior)as reported in the international studies. In the randomized group ("F") primary endpoints will be the clinical cure rate at various time points, global cure rate at 10 weeks, time to clinical cure and time to global cure, while as secondary endpoints the cost effectiveness, quality of life, mortality will be assessed also. Our hypothesis is, that FMT with the BMS is superior to vancomycin treatment in terms of primary and secondary endpoints for these patients.
- Conditions
- Clostridium Difficile Infection
- Being tested
- faecal human microbiota transplant (FMT), Vancomycin or Fidaxomicin
- Keywords
- fecal microbiota transplantation (FMT), Clostridium difficile infection, gut flora, human microbiome, colitis
- Medical subject headings
- Clostridium Infections, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
faecal human microbiota transplant (FMT)Biological
Also called FMT
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.
Vancomycin or FidaxomicinDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Recurrent CDI FMT | Experimental | Non-randomized group ("R") for treatment of recurrent CDI with FMT Receives: Biological: faecal human microbiota transplant (FMT) |
| Primary CDI antibiotic | Active comparator | Randomized group ("F" AB) for the treatment of primary CDI with antibiotics (vancomycin or fidaxomicin) Receives: Drug: Vancomycin or Fidaxomicin |
| Primary CDI FMT | Experimental | Randomized group ("F" FMT) for the treatment of primary CDI with FMT Receives: Biological: faecal human microbiota transplant (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cure rate at 10 weeks
Measured: 10 weeks after enrolment
Time to clinical cure
The number of days between enrolment and the resolution of diarrhoea
Measured: 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
Measured: Through study completion, an average of 18 months
Cure rate at 2 weeks
Measured: 2 weeks after enrolment
Cure rate at 4 weeks
Measured: 4 weeks after enrolment
Treatment failure rate
Measured: Through study completion, an average of 18 months
Recurrence rate 8 weeks after clinical cure
Measured: 8 weeks after clinical cure
Secondary outcomes (9)
Number of adverse events (AE)
Number of participants with treatment related adverse events
Measured: Through study completion, an average of 18 months
Number of serious adverse events (SAE)
Number of participants with treatment related serious adverse events
Measured: Through study completion, an average of 18 months
Time of hospitalization
Measured: Through study completion, an average of 18 months
Days without diarrhoea during study period
Measured: Through study completion, an average of 18 months
Patient related quality of life
Measured with EuroQoL 5Q-TL questionnaire
Measured: 0, 7, 14 days after enrolment
Professional acceptance
A modified TSQM-14 questionnaire for assessing professional acceptance will be used during the study
Measured: Through study completion, an average of 18 months
General health survey for patients
Measured with SF-36v2 questionnaire
Measured: 0, 7, 14 days after enrolment
Patient anxiety and depression
Measured with HAD Scale (HADS)
Measured: 0, 14, 70 days after enrolment
Patient acceptance of treatment
Measure with TSQM-14 questionnaire
Measured: 14,70 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sejtterapia Kozpont Kft.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Debrecen, Kenézy Gyula Korhaz es Rendelointezet, Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhaz, Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Bacs-Kiskun Megyei Korhaz, UD-Genomed Kft.
- Responsible party
- Sponsor
- Investigators
- Gergely G Nagy, M.D., Ph.D., Study chair, University of DebrecenZoltan Szilvassy, M.D., D.Sc., Study director, University of DebrecenGyorgy Paragh, M.D., D.Sc., Principal investigator, University of DebrecenIstvan Varkonyi, M.D., Principal investigator, Kenezy Gyula Korhaz es RendelointezetZoltan Fulep, M.D., Principal investigator, Bacs-Kiskun Megyei KorhazLaszlo Szegedi, M.D., Principal investigator, Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi OktatokorhazTibor Pap, M.D., Principal investigator, Miskolci Semmelweis Korhaz es Egyetemi OktatokorhazLaszlo Nagy, M.D., D.Sc., Principal investigator, UD-Genomed Kft.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053505
- Sponsor's protocol ID
- FMT01
- Acronym
- FMTREAT
- Status last verified
- Mar 2017
- First submitted
- 18 Jan 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37096495
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03053505
- Acronym / sponsor ID
- FMTREAT / FMT01
- Conditions
- Clostridium Difficile Infection
- Keywords
- fecal microbiota transplantation (FMT), Clostridium difficile infection, gut flora, human microbiome, colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sejtterapia Kozpont Kft.Industry (pharma, biotech, devices)
- Collaborators
- University of Debrecen, Kenézy Gyula Korhaz es Rendelointezet, Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhaz, Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Bacs-Kiskun Megyei Korhaz, UD-Genomed Kft.
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clostridium difficile is an anaerobe, spore-forming bacillus. Infections with its toxin-producing strains are capable of causing CD associated enteral disease ranging in severity from mild diarrhea to fatal fulminant colitis. CD infection(CDI) occurs among patients who have taken antibiotics previously, suggesting that the normal gut flora is capable of preventing CDI. The disease is mainly treated with antibiotics, however, these antibiotics show high therapeutic failure and recurrence rates. There is significant interest in the development of alternative therapeutic strategies. Among the alternative methods only faecal microbiota transplantation (FMT) is gaining acceptance due to its excellent cure rate and low recurrence rate. FMT is a new approach to treating CDI, since no further antibiotics are administered, instead the normal gut flora being restored by administering faecal homogenisate from a healthy donor. Immediate risks of FMT are minimal, its efficacy is excellent,but further data is required about its short and long term safety, its most appropriate timing during the course of CDI and the optimal technical protocol for preparing the fecal homogenisate. In addition, the procedure is also challenging and the intervention itself is unappealing in nature. To address the challenges described above a novel faecal transplantation system has been designed (Burgin-Matic System, BMS), which is suitable for the production of faecal bacterial suspension in a standardized and controlled environment. Using this new approach, a multi-center,prospective,interventional clinical study involving two groups of patients has been designed: 1. In a non-randomized group("R") the safety and efficacy of FMT with the new, automated transplantation system will be assessed on 50 patients suffering from "R"ecurrent CDI. 2. In a randomized group ("F") FMT will be compared with the gold standard vancomycin treatment for 2x50 patients, with their "F"irst episode of CDI, suffering from severe infection or at risk of developing recurrent or severe disease and not responding to at least 72 hours of antibiotic treatment. In the non-randomized group("R"), the safety and efficacy of FMT will be assessed,with the hypothesis that FMT with the BMS is equally safe and effective(non-inferior)as reported in the international studies. In the randomized group ("F") primary endpoints will be the clinical cure rate at various time points, global cure rate at 10 weeks, time to clinical cure and time to global cure, while as secondary endpoints the cost effectiveness, quality of life, mortality will be assessed also. Our hypothesis is, that FMT with the BMS is superior to vancomycin treatment in terms of primary and secondary endpoints for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recurrent CDI FMT | Experimental | Biological: faecal human microbiota transplant (FMT)Non-randomized group ("R") for treatment of recurrent CDI with FMT |
| Primary CDI antibiotic | Active comparator | Drug: Vancomycin or FidaxomicinRandomized group ("F" AB) for the treatment of primary CDI with antibiotics (vancomycin or fidaxomicin) |
| Primary CDI FMT | Experimental | Biological: faecal human microbiota transplant (FMT)Randomized group ("F" FMT) for the treatment of primary CDI with FMT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| faecal human microbiota transplant (FMT)Also: FMTNon-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. | Biological | Primary CDI FMT, Recurrent CDI FMT |
| Vancomycin or FidaxomicinRandomized 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). | Drug | Primary CDI antibiotic |
Primary outcome
Global cure rate at 10 weeks
Time frame: 10 weeks after enrolment
Time to clinical cure
Time frame: Through study completion, an average of 18 months
The number of days between enrolment and the resolution of diarrhoea
Time to global cure
Time frame: Through study completion, an average of 18 months
The number of days between enrolment and the resolution of diarrhoea without relapse
Cure rate at 2 weeks
Time frame: 2 weeks after enrolment
Cure rate at 4 weeks
Time frame: 4 weeks after enrolment
Treatment failure rate
Time frame: Through study completion, an average of 18 months
Recurrence rate 8 weeks after clinical cure
Time frame: 8 weeks after clinical cure
9 secondary outcomes
Number of adverse events (AE)
Time frame: Through study completion, an average of 18 months
Number of serious adverse events (SAE)
Time frame: Through study completion, an average of 18 months
Time of hospitalization
Time frame: Through study completion, an average of 18 months
Days without diarrhoea during study period
Time frame: Through study completion, an average of 18 months
Patient related quality of life
Time frame: 0, 7, 14 days after enrolment
Professional acceptance
Time frame: Through study completion, an average of 18 months
General health survey for patients
Time frame: 0, 7, 14 days after enrolment
Patient anxiety and depression
Time frame: 0, 14, 70 days after enrolment
Patient acceptance of treatment
Time frame: 14,70 days after enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Derived from this study: PubMed 37096495Minkoff 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gergely G Nagy, M.D., Ph.D. study chair
University of Debrecen
Zoltan Szilvassy, M.D., D.Sc. study director
University of Debrecen
Gyorgy Paragh, M.D., D.Sc. principal investigator
University of Debrecen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing faecal human microbiota transplant (FMT) and Vancomycin or Fidaxomicin in people with Clostridium Difficile Infection, run by Sejtterapia Kozpont Kft. at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gergely G Nagy, M.D., Ph.D. (0036209547016, ngergely@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cure rate at 10 weeks (time frame: 10 weeks after enrolment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03053505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.