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Table 3 Ongoing clinical trials of microbiota intervention in the treatment and prevention of aGVHD

From: Roles of the intestinal microbiota and microbial metabolites in acute GVHD

Study title

Interventions

Phases

NCT Number

Antibiotics

 Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

Procedure: Optimization cohort;

Procedure: Control cohort

N/A

NCT03727113

 Gut Decontamination In Pediatric Allogeneic Hematopoietic

Drug: Vancomycin-polymyxin B

Phase 2

NCT02641236

 Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant

Drug: Cyclophosphamide; Drug: Etoposide;

Drug: Goat Milk; Biological: Palifermin;

Drug: Sirolimus; Drug: Tacrolimus

Phase 1

NCT04177004

Prebiotics

 Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patient

Drug: potato-starch; Other: Starch Placebo

Phase 2

NCT02763033

 The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients

Drug: Inulin; Drug: Placebos

N/A

NCT04111471

 Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients

Drug: 2'-fucosyllactose;

Other: Placebo (2 g oral glucose)

Phase 1/Phase 2

NCT04263597

 Prebiotic Galacto-oligosaccharide and Acute GVHD

Dietary Supplement: Galacto-oligosaccharide;

Dietary Supplement: Maltodextrin

Phase 1/Phase 2

NCT04373057

 Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

Other: Pre-biotic foods/drinks

N/A

NCT04629430

 High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant

Dietary Supplement: Vitamin A Compound

N/A

NCT03719092

Probiotics

 Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant

Biological: Lactobacillus plantarum strain 299;

Biological: Lactobacillus plantarum strain 299v;

Other: Placebo Administration

Phase 3

NCT03057054

 CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant

Drug: Clostridium butyricum CBM 588 Probiotic Strain;

Other: Best Practice

Phase 1

NCT03922035

 MaaT013 as Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients

Drug: MaaT013, which is made of allogeneic, full-ecosystem pooled biotherapeutic intestinal microbiota

Phase 3

NCT04769895

FMT

 Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Biological: Fecal Microbiota Transplantation; Drug: drug

N/A

NCT04711967

 Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD

Biological: Fecal Microbiota Transplantation

Phase 2

NCT04059757

 FMT In High-Risk Acute GVHD After ALLO HCT

Biological: Fecal Microbiota Transplant

Phase 1

NCT04139577

 Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD

Biological: allogeneic fecal microbiota;

Drug: Ruxolitinib; Drug: Methylprednisone

Phase 1/Phase 2

NCT04269850

 Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease

Drug: Fecal Microbiota Transplantation Capsule

Phase 1

NCT04280471

 FMT for Steroid Resistant Gut Acute GVHD

Biological: Fecal Microbiota Transplantation

Early Phase 1

NCT04285424

 Efficacy and Safety of FMT Capsule Treating Steroid-refractory GI-aGvHD

Biological: Fecal Microbiota Transplant Capsule

N/A

NCT04622475

 Fecal Microbiota Transplantation in aGvHD After ASCT

Biological: Fecal microbiota transplantation

Phase 3

NCT03819803

 Efficacy and Safety of Auto-FMT in Preventing aGVHD

Other: autologous fecal bacteria

Phase 1

NCT04745221

 Fecal Microbiota Transplantation in Gut aGVHD Treated

Biological: Fecal microbiota

None

NCT03148743

 Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

Biological: fecal microbiome transplantation

Phase 2

NCT03812705

 Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study

Biological: Fecal Microbiota Transplantation

Phase 1

NCT03549676

 Safety and Efficacy of Fecal Microbiota Transplantation

Procedure: Fecal Microbiota Transplantation

N/A

NCT04014413

Others

 Randomized, Prospective, Multicenter Study to Compare Enteral Nutrition to Parenteral Nutrition as Feeding Support in Patients Presenting Malignant Hemopathy Who Underwent an Allogeneic Hematopoietic Stem Cell Transplantation

Drug: Enteral nutrition alanyl-glutamin, Dipeptiven

Phase 3

NCT01955772