Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection (FMTREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03053505
Recruitment Status : Unknown
Verified March 2017 by Sejtterapia Kozpont Kft..
Recruitment status was:  Recruiting
First Posted : February 15, 2017
Last Update Posted : March 30, 2017
Sponsor:
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.
Information provided by (Responsible Party):
Sejtterapia Kozpont Kft.

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: faecal human microbiota transplant (FMT) Drug: Vancomycin or Fidaxomicin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Recurrent CDI FMT
Non-randomized group ("R") for treatment of recurrent CDI with FMT
Biological: faecal human microbiota transplant (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.

Other Name: FMT

Active Comparator: Primary CDI antibiotic
Randomized group ("F" AB) for the treatment of primary CDI with antibiotics (vancomycin or fidaxomicin)
Drug: Vancomycin or Fidaxomicin
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).

Experimental: Primary CDI FMT
Randomized group ("F" FMT) for the treatment of primary CDI with FMT
Biological: faecal human microbiota transplant (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.

Other Name: FMT




Primary Outcome Measures :
  1. Global cure rate at 10 weeks [ Time Frame: 10 weeks after enrolment ]
  2. 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

  3. 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

  4. Cure rate at 2 weeks [ Time Frame: 2 weeks after enrolment ]
  5. Cure rate at 4 weeks [ Time Frame: 4 weeks after enrolment ]
  6. Treatment failure rate [ Time Frame: Through study completion, an average of 18 months ]
  7. Recurrence rate 8 weeks after clinical cure [ Time Frame: 8 weeks after clinical cure ]

Secondary Outcome Measures :
  1. Number of adverse events (AE) [ Time Frame: Through study completion, an average of 18 months ]
    Number of participants with treatment related adverse events

  2. Number of serious adverse events (SAE) [ Time Frame: Through study completion, an average of 18 months ]
    Number of participants with treatment related serious adverse events

  3. Time of hospitalization [ Time Frame: Through study completion, an average of 18 months ]
  4. Days without diarrhoea during study period [ Time Frame: Through study completion, an average of 18 months ]
  5. Patient related quality of life [ Time Frame: 0, 7, 14 days after enrolment ]
    Measured with EuroQoL 5Q-TL questionnaire

  6. Professional acceptance [ Time Frame: Through study completion, an average of 18 months ]
    A modified TSQM-14 questionnaire for assessing professional acceptance will be used during the study

  7. General health survey for patients [ Time Frame: 0, 7, 14 days after enrolment ]
    Measured with SF-36v2 questionnaire

  8. Patient anxiety and depression [ Time Frame: 0, 14, 70 days after enrolment ]
    Measured with HAD Scale (HADS)

  9. Patient acceptance of treatment [ Time Frame: 14,70 days after enrolment ]
    Measure with TSQM-14 questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053505


Contacts
Layout table for location contacts
Contact: Gergely G Nagy, M.D., Ph.D. 0036209547016 ngergely@hotmail.com
Contact: Zsuzsa Tudlik, Pharm.D. 0036204197188 drtudlikzsuzsa@sejtterapia.hu

Locations
Layout table for location information
Hungary
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz Recruiting
Miskolc, B-A-Z County, Hungary, 3525
Contact: Tibor Pap, M.D.         
University of Debrecen, Clinical Centre Recruiting
Debrecen, Hajdu-Bihar megye, Hungary, 4032
Contact: Gyorgy Paragh, M.D., D.Sc.         
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Recruiting
Nyiregyhaza, Szabocs-Szatmar-Bereg megye, Hungary, 4400
Contact: Laszlo Szegedi, M.D.         
Sponsors and Collaborators
Sejtterapia Kozpont Kft.
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.
Investigators
Layout table for investigator information
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.

Layout table for additonal information
Responsible Party: Sejtterapia Kozpont Kft.
ClinicalTrials.gov Identifier: NCT03053505     History of Changes
Other Study ID Numbers: FMT01
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sejtterapia Kozpont Kft.:
fecal microbiota transplantation (FMT)
Clostridium difficile infection
gut flora
human microbiome
colitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Vancomycin
Fidaxomicin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents