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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Fecal Microbiota Transplantation | Experimental | Patients will receive autologous fecal microbiota transplantation (MaaT011- 150 mL rectal enema) - 2 administrations 24 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Fecal Microbiota Transplantation | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity | Comparison of Alpha and Beta diversity indexes at baseline, after chemotherapy and after AFMT will be performed | 40 days |
| Evaluation of AFMT efficacy in MDRB eradication based on bacterial culture | MDRB carriage and resistome will be compared at baseline, after chemotherapy and after AFMT | 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Definition of a dysbiosis biosignature using combination of biological parameters | Microbiota sequencing results will be correlated with immune parameters | 40 days |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad Mohty, MD, PhD | APHP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPC | Marseille | 13009 | France | |||
| CHU Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34035290 | Derived | Malard F, Vekhoff A, Lapusan S, Isnard F, D'incan-Corda E, Rey J, Saillard C, Thomas X, Ducastelle-Lepretre S, Paubelle E, Larcher MV, Rocher C, Recher C, Tavitian S, Bertoli S, Michallet AS, Gilis L, Peterlin P, Chevallier P, Nguyen S, Plantamura E, Boucinha L, Gasc C, Michallet M, Dore J, Legrand O, Mohty M. Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients. Nat Commun. 2021 May 25;12(1):3084. doi: 10.1038/s41467-021-23376-6. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Nantes |
| 44000 |
| France |
| Hopital Saint Antoine | Paris | 75012 | France |
| HCL Lyon Sud | Pierre-Bénite | 69310 | France |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |