Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 2 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Safety and efficacy of fecal microbial transplantation for the prevention and treatment of acute graft-versus-host disease: a meta-analysis.Frontiers in microbiology · 2026Pooled it
- Pooled it
- Fecal microbiota transplantation to prevent acute graft-versus-host disease: pre-planned interim analysis of donor effect.Nature communications · 2025Trial
- Potential of Fecal Microbiota Transplantation to Prevent Acute GVHD: Analysis from a Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Trial
- Trial
- The gut microbiome in graft-versus-host disease: mechanisms of immune modulation and therapeutic approaches.Gut microbes · 2026Review
- Fecal Microbiota Transplantation and Microbiota-Based Therapeutics in Allogeneic Hematopoietic Stem Cell Transplantation: Current Evidence and Future Directions.Clinical pharmacology and therapeutics · 2026Review
- Lactic Acid Bacteria-Fermented Natural Products: Mechanisms and Evidence for Ageing- and Stem-Cell-Related Outcomes.Foods (Basel, Switzerland) · 2026Review
- The Role of the Gut Microbiota in Allogeneic Hematopoietic Cell Transplantation.American journal of hematology · 2026Review
- Next-generation probiotics: an outlook into current applications and future developments.Nature reviews. Microbiology · 2026Review
- Acute myeloid leukemia and gut microbiome: bidirectional effects and opportunities for intervention.Annals of hematology · 2026Review
- Profiling the gut resistome to unlock antimicrobial resistance biology and inform clinical risk.Nature communications · 2026Review
- The gut microbiome in solid-organ and haematopoietic-stem-cell transplantation.Nature reviews. Microbiology · 2026Review
- The Role of Gut Microbiota in Acute Myeloid Leukemia.Journal of clinical medicine · 2026Review
- The intestinal microbiota as a key modulator of acute graft-versus-host disease.Nature reviews. Cancer · 2026Review
- The microbial metabolome: remodeling the therapeutic landscape in hematologic malignancies.NPJ biofilms and microbiomes · 2026Review
- Microbiome, GvHD, and immune reconstitution in allogeneic hematopoietic cell transplantation.Bone marrow transplantation · 2026Review
- The Link between Modifiable Risk Factors and Myeloid Disorders-From Plate to Pathogenesis.Blood cancer discovery · 2026Review
- Therapeutic ecology of the fiber-microbiota-barrier axis in leukemia: resilience, immune recovery and pharmacomicrobiomics.Frontiers in microbiology · 2026Review
- Gastrointestinal acute graft versus host disease: a translational perspective from pathogenesis to precision prevention and treatment.Frontiers in immunology · 2026Review
Corrections and comments
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Authors and funding
16 authors at 2 institutions in 1 country.
Funding
Abstract
purposeGut microbiota injury in allogeneic hematopoietic cell transplantation (HCT) recipients and patients with AML has been associated with adverse clinical outcomes. Previous studies in these patients have shown improvements in various microbiome indices after fecal microbiota transplantation (FMT). However, whether microbiome improvements translate into improved clinical outcomes remains unclear. We examined this question in a randomized, double-blind, placebo-controlled phase II trial.
methodsTwo independent cohorts of allogeneic HCT recipients and patients with AML receiving induction chemotherapy were randomly assigned in a 2:1 ratio to receive standardized oral encapsulated FMT versus placebo upon neutrophil recovery. After each course of antibacterial antibiotics, patients received a study treatment. Up to three treatments were administered within 3 months. The primary end point was 4-month all-cause infection rate. Patients were followed for 9 months.
resultsIn the HCT cohort (74 patients), 4-month infection density was 0.74 and 0.91 events per 100 patient-days in FMT and placebo arms, respectively (infection rate ratio, 0.83; 95% CI, 0.48 to 1.42;
conclusionIn allogeneic HCT recipients and patients with AML, third-party FMT was safe and ameliorated intestinal dysbiosis, but did not decrease infections. Novel findings from this trial will inform future development of FMT trials.
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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.