Studies of FMT in patients with hematologic malignancies
| Studies . | Indication . | Underlying disease . | Study type . | n . | Donor type . | Method of delivery . | Total number of FMTs per patient . | Primary clinical outcome . | FMT-related adverse events . | Microbiome changes . | Institutional review or regulatory approval reported . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FMT for steroid-refractory or resistant GVHD | |||||||||||
| Kakihana et al 201621 | Steroid-resistant/dependent GI GVHD | AML + allo-HSCT | Prospective, single-center pilot | 4 | Spouse or relative | ND tube | 1-2 | 3 CR, 1 PR | No | 16S sequencing: patient 1: ↑Lactobacillus and Bacteroides, patient 2: ↓Streptococcus ↑Bacteroides, Lactobacillus, and Bifidobacterium, patient 3: ↑Bacteroides, Bifidobacterium, and Faecalibacterium, [atient 4: ↑Escherichia coli at recurrence | Approved by the institutional ethics committee |
| Spindelboeck et al 201722 | Severe steroid-refractory GI GVHD | AML and MDS + allo-HSCT | Case series | 3 | Unrelated and related | Colonoscopy | 1-6 | 2 CR, 1 PR | No | 16S sequencing: patient 1: ↑richness with resolution, patient 2: ↑richness with resolution, patient 3: ↓richness with recurrence | Approved by the ethics review board of Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital |
| Qi et al 201823 | Steroid-refractory GI GVHD | Acute and chronic leukemias and MDS + allo-HSCT | Retrospective observational cohort | 8 FMT; 8 controls | Unrelated | ND tube | 1-2 | 4 CR (cure), 2 relapse, 1 PR, 1 remission | No | 16S sequencing: ↑diversity, ↓Firmicutes and Enterococcus, ↑Bacteroidetes | Approved by the Institutional Review Board of the First Affiliated Hospital of Soochow University |
| Kaito et al 201824 | Severe steroid-refractory GI GVHD | ALL + allo-HSCT | Case study | 1 | Relative | Oral capsules of pelleted stool | 7 | 1 PR | No | 16S sequencing: ↑diversity and ↑Bacteroides, Parabacteroides, Clostridium, Faecalibacterium, Lactobacillus | A priori permission of the hospital board of the LKH Universitätsklinikum Graz and after obtaining informed consent. Publication was approved by the local institutional review board |
| FMT for the prevention of HSCT complications | |||||||||||
| Taur et al 201827 | Dysbiosis following allo-HSCT, Bacteroidetes ≦0.1% | Acute and chronic leukemias, MDS, MM, NHL + allo-HSCT | Pilot study within an RCT | FMT, n=14; no FMT, n=11 | Auto-FMT | Retention enema | 1 | NA | None | 16S and shotgun metagenomics: ↑diversity, Lachnospiraceae, Ruminococcacae, Bacteroidetes | Approved by the Memorial Sloan Kettering Cancer Center Institutional Review and Privacy Board |
| DeFilipp et al 201826 | Post-allo-HSCT | Acute and chronic leukemias, NHL, MDS, MPD, and MF + allo-HSCT | Prospective, single-arm pilot study | 13 | Unrelated | Oral capsules | 1 | 85% OS and 85% PFS. 2 deaths in total with 1 death due to acute GI GVHD | 1 SAE (grade 3 abdominal pain) | 16S sequencing: ↑diversity and expansion of stool donor taxa, ↑Clostridiales abundance | Approved by the Institutional Review Board at the Dana-Farber Harvard Cancer Center and conducted under IND 16857 |
| FMT for intestinal decolonization of MDROs | |||||||||||
| Biliński et al 201629 | Gut colonization with NDM+ Klebiella pneumoniae and ESBL+ Escherichia coli | MM + auto-HSCT | Case report | 1 | Unrelated | ND tube | 1 | NA | No | Not assessed | Reviewed and accepted by the Bioethical Committee of the Medical University of Warsaw |
| Biliński et al 201730 | MDRO gut colonization | Immunocompromised (includes hematologic malignancies, and patients post-HSCT with GVHD) | Prospective cohort | 20 (25 FMTs) | Unrelated | ND tube | 1-3 | NA | No | 16S sequencing: ↑Barnesiella, Bacteroides, and Butyricimonas, ↑richness | Approved by The Medical University of Warsaw Ethics Committee approved the research protocol |
| Innes et al 201731 | Gut colonization with carbapenemase-producing Klebsiella oxytoca | ALL, prior to allo-HSCT | Case report | 1 | Unrelated | NG tube | 1 | NA | No | Not assessed | None noted |
| Battipaglia et al 201932 | MDR gut colonization with carbapenamase + Enterobacteriaceae or Pseudomonas aeruginosa | Hematologic malignancies before or after allo-HSCT | Retrospective | 10 | Related and unrelated | Enema or NG tube | 1-2 | MA | No | Not assessed | Approved by the institutional ethics committees |
| Studies . | Indication . | Underlying disease . | Study type . | n . | Donor type . | Method of delivery . | Total number of FMTs per patient . | Primary clinical outcome . | FMT-related adverse events . | Microbiome changes . | Institutional review or regulatory approval reported . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FMT for steroid-refractory or resistant GVHD | |||||||||||
| Kakihana et al 201621 | Steroid-resistant/dependent GI GVHD | AML + allo-HSCT | Prospective, single-center pilot | 4 | Spouse or relative | ND tube | 1-2 | 3 CR, 1 PR | No | 16S sequencing: patient 1: ↑Lactobacillus and Bacteroides, patient 2: ↓Streptococcus ↑Bacteroides, Lactobacillus, and Bifidobacterium, patient 3: ↑Bacteroides, Bifidobacterium, and Faecalibacterium, [atient 4: ↑Escherichia coli at recurrence | Approved by the institutional ethics committee |
| Spindelboeck et al 201722 | Severe steroid-refractory GI GVHD | AML and MDS + allo-HSCT | Case series | 3 | Unrelated and related | Colonoscopy | 1-6 | 2 CR, 1 PR | No | 16S sequencing: patient 1: ↑richness with resolution, patient 2: ↑richness with resolution, patient 3: ↓richness with recurrence | Approved by the ethics review board of Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital |
| Qi et al 201823 | Steroid-refractory GI GVHD | Acute and chronic leukemias and MDS + allo-HSCT | Retrospective observational cohort | 8 FMT; 8 controls | Unrelated | ND tube | 1-2 | 4 CR (cure), 2 relapse, 1 PR, 1 remission | No | 16S sequencing: ↑diversity, ↓Firmicutes and Enterococcus, ↑Bacteroidetes | Approved by the Institutional Review Board of the First Affiliated Hospital of Soochow University |
| Kaito et al 201824 | Severe steroid-refractory GI GVHD | ALL + allo-HSCT | Case study | 1 | Relative | Oral capsules of pelleted stool | 7 | 1 PR | No | 16S sequencing: ↑diversity and ↑Bacteroides, Parabacteroides, Clostridium, Faecalibacterium, Lactobacillus | A priori permission of the hospital board of the LKH Universitätsklinikum Graz and after obtaining informed consent. Publication was approved by the local institutional review board |
| FMT for the prevention of HSCT complications | |||||||||||
| Taur et al 201827 | Dysbiosis following allo-HSCT, Bacteroidetes ≦0.1% | Acute and chronic leukemias, MDS, MM, NHL + allo-HSCT | Pilot study within an RCT | FMT, n=14; no FMT, n=11 | Auto-FMT | Retention enema | 1 | NA | None | 16S and shotgun metagenomics: ↑diversity, Lachnospiraceae, Ruminococcacae, Bacteroidetes | Approved by the Memorial Sloan Kettering Cancer Center Institutional Review and Privacy Board |
| DeFilipp et al 201826 | Post-allo-HSCT | Acute and chronic leukemias, NHL, MDS, MPD, and MF + allo-HSCT | Prospective, single-arm pilot study | 13 | Unrelated | Oral capsules | 1 | 85% OS and 85% PFS. 2 deaths in total with 1 death due to acute GI GVHD | 1 SAE (grade 3 abdominal pain) | 16S sequencing: ↑diversity and expansion of stool donor taxa, ↑Clostridiales abundance | Approved by the Institutional Review Board at the Dana-Farber Harvard Cancer Center and conducted under IND 16857 |
| FMT for intestinal decolonization of MDROs | |||||||||||
| Biliński et al 201629 | Gut colonization with NDM+ Klebiella pneumoniae and ESBL+ Escherichia coli | MM + auto-HSCT | Case report | 1 | Unrelated | ND tube | 1 | NA | No | Not assessed | Reviewed and accepted by the Bioethical Committee of the Medical University of Warsaw |
| Biliński et al 201730 | MDRO gut colonization | Immunocompromised (includes hematologic malignancies, and patients post-HSCT with GVHD) | Prospective cohort | 20 (25 FMTs) | Unrelated | ND tube | 1-3 | NA | No | 16S sequencing: ↑Barnesiella, Bacteroides, and Butyricimonas, ↑richness | Approved by The Medical University of Warsaw Ethics Committee approved the research protocol |
| Innes et al 201731 | Gut colonization with carbapenemase-producing Klebsiella oxytoca | ALL, prior to allo-HSCT | Case report | 1 | Unrelated | NG tube | 1 | NA | No | Not assessed | None noted |
| Battipaglia et al 201932 | MDR gut colonization with carbapenamase + Enterobacteriaceae or Pseudomonas aeruginosa | Hematologic malignancies before or after allo-HSCT | Retrospective | 10 | Related and unrelated | Enema or NG tube | 1-2 | MA | No | Not assessed | Approved by the institutional ethics committees |
AML, acute myeloid leukemia; ATG, anti-thymocyte globulin; CR, complete remission; FMT, fecal microbiota transplant; MDRO, multidrug-resistant organisms; MDS, myelodysplastic syndrome; MF, myelofibrosis; MM, multiple myeloma; MPD, myeloproliferative disorder; ND, nasoduodenal; NDM, New Delhi metallo-β-lactamase type carbapenamase; NG, nasogastric; NHL, non-Hodgkin lymphoma; OS, overall survival; PFS, progression-free survival; PR, partial remission; SAE, serious adverse event; TPN, total parenteral nutrition; XDRO, extensively drug resistant organism.