Clinical Trial: PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and

Brief Summary: The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at the time of admission and AML diagnosis, patients will be requested to donate stools that will be comprehensively screened, and if deemed appropriate according to protocol criteria, conditioned and stored frozen until future processing and transplantation after aplasia completion.

Detailed Summary:
Sponsor: MaaT Pharma

Current Primary Outcome:

  • Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity [ Time Frame: 40 days ]
  • Evaluation of AFMT efficacy in MDRB eradication based on bacterial culture [ Time Frame: 40 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Definition of a dysbiosis biosignature using combination of biological parameters [ Time Frame: 40 days ]

Original Secondary Outcome: Same as current

Information By: MaaT Pharma

Dates:
Date Received: May 26, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: October 6, 2016
Last Verified: October 2016