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PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment (ODYSSEE)

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ClinicalTrials.gov Identifier: NCT02928523
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE October 10, 2016
Last Update Posted Date June 25, 2018
Study Start Date  ICMJE June 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02928523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
Definition of a dysbiosis biosignature using combination of biological parameters [ Time Frame: 40 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment
Official Title  ICMJE PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid, Acute
Intervention  ICMJE Drug: Autologous Fecal Microbiota Transplantation
Study Arms  ICMJE Experimental: Autologous Fecal Microbiota Transplantation
Intervention: Drug: Autologous Fecal Microbiota Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)
20
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2016)
35
Actual Study Completion Date  ICMJE June 20, 2018
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ≥ 18 and ≤ 75 years old with de novo diagnosis of AML or high-risk myelodysplastic syndrom for whom intensive induction chemotherapy is anticipated within 10 days after admission
  • Patients willing to donate stool samples and to follow protocol recommendations
  • Signature of informed and written consent

Exclusion Criteria:

  • Acute promyelocytic leukemia (AML-M3)
  • Known allergy or intolerance to trehalose or maltodextrin
  • Pregnancy: positive urinary or blood test in female of childbearing potential
  • Severe disease with a life expectancy < 3 months
  • Other ongoing interventional protocol that might interfere with the study
  • Non eligibility for collection of autologous stools upon admission:

    • Patients refusing to consent
    • Antibiotherapy at the time of study inclusion ≥ 4 days
    • Concomitant or previous diagnosis of a significant inflammatory bowel disease (UC, CD) or other progressive digestive disease requesting treatment or further medical exploration
    • Presence of severe colitis of any etiology at the time of admission or severe digestive disorders (acute or chronic diarrhea) within 3 months preceding inclusion
    • Patient getting a recent colonoscopy (within 3 months preceding inclusion)
  • Detection of MDRB, pathogenic bacteria, parasites, norovirus and/or rotavirus during screening of autologous stool collected at baseline
  • Non eligibility for inoculum transplantation: persistent mucositis, colitis, or haemorrhoids, presence of blood in more than 50% of patient's faeces the week preceding the transplantation
  • Non feasibility of inoculum procedure: patient refusal; technical or biological mismatch of the inoculum
  • Absence of effective contraceptive method for female of childbearing potential
  • Lactation
  • Inability to give an informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02928523
Other Study ID Numbers  ICMJE MPOH02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party MaaT Pharma
Study Sponsor  ICMJE MaaT Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MaaT Pharma
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP