PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients

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