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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03053505

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sejtterapia Kozpont Kft.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Gergely G Nagy, M.D., Ph.D.Zoltan Szilvassy, M.D., D.Sc.Gyorgy Paragh, M.D., D.Sc.Istvan Varkonyi, M.D.Zoltan Fulep, M.D.Laszlo Szegedi, M.D.Tibor Pap, M.D.Laszlo Nagy, M.D., D.Sc.Eva Rakoczi, M.D.Judit Szabo, M.D., Ph.D.Maria Papp, M.D., Ph.D.Peter Vajo
Principal Investigator Affiliation University of DebrecenUniversity of DebrecenUniversity of DebrecenKenezy Gyula Korhaz es RendelointezetBacs-Kiskun Megyei KorhazSzabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi OktatokorhazMiskolci Semmelweis Korhaz es Egyetemi OktatokorhazUD-Genomed Kft.Kenezy Gyula Korhaz es RendelointezetUniversity of DebrecenUniversity of DebrecenSejtterapia Kozpont Kft.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
IndustryOtherOtherOtherOtherOtherOther
Overall Status Recruiting
Countries Hungary

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Clostridium Difficile Infection
Additional Details

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.

Contact a Trial Team

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International Sites

Miskolc, B-A-Z County, Hungary

Status

Recruiting

Address

Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

Miskolc, B-A-Z County, 3525

Site Contact

Tibor Pap, M.D.

0036209547016

University of Debrecen, Clinical Centre, Debrecen, Hajdu-Bihar megye, Hungary

Status

Recruiting

Address

University of Debrecen, Clinical Centre

Debrecen, Hajdu-Bihar megye, 4032

Site Contact

Gyorgy Paragh, M.D., D.Sc.

0036209547016

Nyiregyhaza, Szabocs-Szatmar-Bereg megye, Hungary

Status

Recruiting

Address

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyiregyhaza, Szabocs-Szatmar-Bereg megye, 4400

Site Contact

Laszlo Szegedi, M.D.

0036209547016

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