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. 2022 Jan 29;14(3):691. doi: 10.3390/cancers14030691

Table 3.

Clinical studies registered in Clinicaltrials.gov for hematologic and oncologic patients in the US and in Europe.

NCT# Study Primary Outcome Measurements Number of Patients (n)
02928523 PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients (ODYSSEE) Evaluation of efficacy in dysbiosis correction and multidrug resistant bacteria based on bacterial culture 20
03678493 A Study of FMT in Patients With AML Allo HSCT in Recipients Efficacy of FMT in AML patients and allo-HSCT recipients in reducing the incidence of infections 120
04935684 Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation (TMF-Allo) GVHD and relapse-free survival rate after allogeneic hematopoietic stem cell transplantation 150
04269850 Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD (JAK-FMT) Overall survival 20
05094765 Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD Overall survival and Grade 3 or above adverse events 15
02269150 Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation CDI up to one year after entry into study 59
03214289 Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease Serious adverse events 4
02733744 Fecal Microbiota Transplantation After HSCT Feasibility on the number of participants able to ingest 15 FMT capsules over a 2-day period 18
03359980 Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer (HERACLES) Efficacy of FMT in steroid refractory -gastro-intestinal acute GVHD at Day 28 24
03819803 Fecal Microbiota Transplantation in aGvHD After ASCT Remission at Day 90 15
04038619 Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients Tolerability and response 40
02770326 Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection Incidence of CDI 10
04116775 Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer. Anticancer effect of FMT from responders to pembrolizumab to non-responders. 32
04040712 Fecal Microbiota Transplantation in Diarrhea Induced by Tyrosine-kinase Inhibitors Resolution of diarrhea four weeks after FMT 20
03819296 Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer Differences in stool microbiome pattern and adverse events 800
04951583 Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma (FMT-LUMINATE) Overall response rate 70
04521075 A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC Overall response rate and adverse events 42
04163289 Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation (PERFORM) Rate of immune-related colitis associated with ipilimumab/nivolumab treatment 20
04729322 Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders Overall response rate 15
04924374 Microbiota Transplant in Advanced Lung Cancer Treated With Immunotherapy Measurements of safety 20
03341143 Fecal Microbiota Transplant (FMT) in Melanoma Patients Overall response rate 18
03353402 Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy Rate of adverse events and engraftment 40
04988841 Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma (PICASSO) Safety and tolerability 60
04577729 The IRMI-FMT Trial Progression-free survival 60