Table 4.
List of ongoing trials for treatment and prevention of acute GVHD with fecal microbiota transplantation.
| Title | Aim | Route of Administration | Design, N, Location | |
|---|---|---|---|---|
| NCT03819803 | Fecal microbiota transplantation in a GVHD after ASCT | FMT for treatment of steroid-dependent/resistant GI acute GVHD | Colonoscopy | Single arm, N = 15, Austria |
| NCT03812705 | Fecal microbiota transplantation for steroid-resistant/dependent acute GI GVHD (FEMITGIGVHD) | FMT for treatment of steroid-dependent/resistant GI acute GVHD | Colonoscopy or gastroscopy | Single arm, Phase 2, N = 30, China |
| NCT03549676 | Fecal microbiota transplantation for treatment of refractory graft-versus-host disease: a pilot study | FMT for treatment of steroid dependent/resistant GI Acute GVHD (pediatric population) | Naso-jejunal tube | Single arm, Phase 1, N = 15, China |
| NCGT03492502 | Autologous fecal microbiota transplantation for patients with acute graft-versus-host disease | Autologous FMT for treatment of steroid-dependent/resistant GI acute GVHD | n/a | Single arm, N = 70, Israel |
| NCT03214289 | Fecal microbiota transplantation for steroid-resistant and steroid-dependent gut acute graft-versus-host disease | FMT for treatment of steroid-dependent/resistant GI acute GVHD | Oral capsules | Single arm, Phase I, N = 4, Israel |
| NCT03148743 | Fecal microbiota transplantation in gut a GVHD | FMT for treatment of GI acute GVHD | Naso-duodenal tube | Single arm, Phase I, N = 20, China |
| NCT03359980 | Treatment of steroid refractory gastrointestinal Acute GVHD after allogeneic HSCT with fecal microbiota transfer (HERACLES) | Fecal microbiota transfer for treatment of steroid-dependent/resistant GI acute GVHD | Enema | Single arm, Phase II, N = 32, Europe |
| NCT03720392 | Fecal microbiota transplantation (FMT) in recipients after allogeneic hematopoietic cell transplantation (HCT) | FMT for prevention of complications and microbiota restoration in allo-HSCT recipients | Oral capsules | Two arms, phase II, randomized, N = 48, United States |
| NCT03678493 | A study of FMT in patients with AML allo HSCT in recipients | FMT for prevention of complications and microbiota restoration in allo-HSCT recipients and AML patients | Oral capsules | Four arms, Phase II, randomized, double-blind, placebo-controlled, N = 120, United States |
Abbreviation: FMT: Fecal microbiota transplantation, GI: Gastrointestinal, GVHD: Graft-versus-host disease, Allo-HSCT: Allogeneic hematopoietic stem cell transplantation, AML: Acute myeloid leukemia.