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

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.

Conditions

• Clostridium Difficile Infection

Interventions

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.

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).

Sponsors & Collaborators

• University of Debrecen

  collaborator OTHER

• Kenézy Gyula Korhaz es Rendelointezet

  collaborator UNKNOWN

• Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhaz

  collaborator UNKNOWN

• Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

  collaborator UNKNOWN

• Bacs-Kiskun Megyei Korhaz

  collaborator UNKNOWN

• UD-Genomed Kft.

  collaborator UNKNOWN

• Sejtterapia Kozpont Kft.

  lead INDUSTRY

Principal Investigators

• Gergely G Nagy, M.D., Ph.D. · University of Debrecen

• Zoltan Szilvassy, M.D., D.Sc. · University of Debrecen

• Gyorgy Paragh, M.D., D.Sc. · University of Debrecen

• Istvan Varkonyi, M.D. · Kenezy Gyula Korhaz es Rendelointezet

• Zoltan Fulep, M.D. · Bacs-Kiskun Megyei Korhaz

• Laszlo Szegedi, M.D. · Szabolcs-Szatmar-Bereg Megyei Korhaz es Egyetemi Oktatokorhaz

• Tibor Pap, M.D. · Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

• Laszlo Nagy, M.D., D.Sc. · UD-Genomed Kft.

• Eva Rakoczi, M.D. · Kenezy Gyula Korhaz es Rendelointezet

• Judit Szabo, M.D., Ph.D. · University of Debrecen

• Maria Papp, M.D., Ph.D. · University of Debrecen

• Peter Vajo · Sejtterapia Kozpont Kft.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2017-12-31

Completion

2018-10-31

Countries

• Hungary

Study Locations