Evidence map›Paper›PMID 34035290›Full record

Trial reportNature communications2021

Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients.

Florent Malard, Anne Vekhoff, Simona Lapusan, Francoise Isnard, Evelyne D'incan-Corda, Jérôme Rey, Colombe Saillard, Xavier Thomas, Sophie Ducastelle-Lepretre, Etienne Paubelle and 17 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 60 papers.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed
5.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02928523 phase1 / phase2completednot on this map

PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY

TypeinterventionalSponsorMaaT PharmaRan2016 to 2018Enrolled20ConditionsLeukemia, Myeloid, AcuteArmsAutologous Fecal Microbiota Transplantation
NCT06355583 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

TypeinterventionalSponsorImperial College LondonRan2024 to 2027Enrolled50ConditionsAcute Lymphoblastic Leukaemia, Acute Leukemia of Ambiguous Lineage, Chronic Myeloid Leukemia, Chronic Myelomonocytic LeukemiaArmsEBX-102, Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 90 citations in OpenAlex.

  1. Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  2. Review
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  5. The Role of Gut Microbiota in Acute Myeloid Leukemia.Journal of clinical medicine · 2026
    Review
  6. Review
  7. Review
  8. Variations in the Gut Microbiota of Stray and Domestic Cats.Animals : an open access journal from MDPI · 2026
    Article
  9. Review
  10. Review
  11. Review
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  13. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 9 institutions in 2 countries.

Florent MalardService d'hématologie clinique et de thérapie cellulaire, Hôpital Saint Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France. florent.malard@inserm.fr.ORCID 0000-0002-3474-0002
Anne VekhoffService d'hématologie clinique et de thérapie cellulaire, Hôpital Saint Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France.
Simona LapusanService d'hématologie clinique et de thérapie cellulaire, Hôpital Saint Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France.
Francoise IsnardService d'hématologie clinique et de thérapie cellulaire, Hôpital Saint Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France.
Evelyne D'incan-CordaService d'hématologie, Institut Paoli Calmettes, Marseille, France.
Jérôme ReyService d'hématologie, Institut Paoli Calmettes, Marseille, France.
Colombe SaillardService d'hématologie, Institut Paoli Calmettes, Marseille, France.
Xavier ThomasService d'hématologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.
Sophie Ducastelle-LepretreService d'hématologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.
Etienne PaubelleService d'hématologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.
Marie-Virginie LarcherService d'hématologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.
Clément RocherService d'hématologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.
Christian RecherCHU de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III Paul Sabatier, Service d'hématologie, Toulouse, France.ORCID 0000-0002-3332-4525
Suzanne TavitianCHU de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III Paul Sabatier, Service d'hématologie, Toulouse, France.
Sarah BertoliCHU de Toulouse, Institut Universitaire du Cancer de Toulouse Oncopole, Université de Toulouse III Paul Sabatier, Service d'hématologie, Toulouse, France.ORCID 0000-0003-1084-2781
Anne-Sophie MichalletService d'hématologie, Centre Léon Bérard, Lyon, France.
Lila GilisService d'hématologie, Centre Léon Bérard, Lyon, France.
Pierre PeterlinService d'hématologie, CHU Nantes, Nantes, France.
Patrice ChevallierService d'hématologie, CHU Nantes, Nantes, France.
Stéphanie NguyenService d'hématologie clinique, Hôpital de la Pitié Salpétrière, APHP, Sorbonne Université, Paris, France.
Emilie PlantamuraMaaT Pharma, Lyon, France.
Lilia BoucinhaMaaT Pharma, Lyon, France.
Cyrielle GascMaaT Pharma, Lyon, France.
Mauricette MichalletService d'hématologie, Centre Léon Bérard, Lyon, France.
Joel DoreUniversité Paris-Saclay, INRAE, MetaGenoPolis, AgroParisTech, MICALIS, Jouy-en-Josas, France.
Ollivier LegrandService d'hématologie clinique et de thérapie cellulaire, Hôpital Saint Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France.
Mohamad MohtyService d'hématologie clinique et de thérapie cellulaire, Hôpital Saint Antoine, APHP, Sorbonne Université, INSERM UMRs 938, Paris, France.
Inserm · FRHospices Civils de Lyon · FRCentre Léon Bérard · FRErytech Pharma (France) · FRInstitut Paoli-Calmettes · FRUniversité Toulouse III - Paul Sabatier · FRCentre Hospitalier Universitaire de Nantes · FRAgroParisTech · FRSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.gov number: NCT02928523). 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. Intensive induction chemotherapy induces a dramatic decrease of α-diversity indices, and a microbial dysbiosis with a significant shift of the microbial communities and domination of pro-inflammatory families. After AFMT treatment, α-diversity indices return to their initial mean levels and the similarity index shows the restoration of microbial communities. 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.

Indexed as

Acute DiseaseAdultAgedAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsBacteriaDysbiosisFecal Microbiota TransplantationFecesFemaleGastrointestinal MicrobiomeHumansLeukemia, MyeloidMaleMiddle AgedProspective StudiesAnti-Bacterial Agents

Identifiers

PMID34035290
PMCPMC8149453
OpenAlexW3164126481

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.