Official websites use. Share sensitive information only on official, secure websites. Acute myeloid leukemia AML intensive chemotherapy combined with broad-spectrum antibiotics, leads to gut microbiota dysbiosis promoting pathological conditions and an increased incidence of complications. Here we report findings from a phase II single-arm, multicenter study evaluating autologous fecal microbiota transfer AFMT in 25 AML patients treated with intensive chemotherapy and antibiotics ClinicalTrials.
The co-primary outcomes of the study are to evaluate the efficacy of AFMT in dysbiosis correction and multidrug-resistant bacteria eradication. The main secondary outcomes are to define a dysbiosis biosignature, to evaluate the effect of dysbiosis correction on patient clinical status, to assess the short and mid-term safety of AFMT in this immunocompromised population, and to evaluate the feasibility of the AFMT procedure and acceptability by the patient.
The trial meets pre-specified endpoints. AFMT appears to be safe and may be effective for gut microbiota restoration in AML patients receiving intensive chemotherapy and antibiotics, with an excellent gut microbiota reconstruction based on both richness and diversity indices at the species level.
The combination of chemotherapy and broad-spectrum antibiotics induces gut microbiota GM dysbiosis in acute myeloid leukaemia AML leading to additional complications.
Here, the authors report the efficacy in GM restoration and safety of autologous faecal microbiota transfer in treated AML patients in a phase II clinical trial. Acute myeloid leukemia AML is a rare but potentially fatal blood cancer. The standard treatment for AML relies on conventional chemotherapy with or without allogeneic hematopoietic cell transplantation alloHCT.
