Table 4.
Summary of ongoing microbiota-linked (not)recruiting clinical trials for GVHD.
| Number | Trail title | Interventions | Aims | Study design | Phase | Patients | Time |
|---|---|---|---|---|---|---|---|
| NCT03819803 | Fecal microbiota transplantation in aGVHD after ASCT | FMT | To explore the employment of FMT in GI-aGVHD. | Single group assignment Open label |
III | 15 | 2017/3/1-2020/12/31 |
| NCT04285424 | FMT for steroid resistant gut acute GVHD | FMT | To evaluate safety and efficacy of FMT for the treatment of steroid resistant GVHD of the gut. | Single group assignment Open label |
Early I | 30 | 2020/3/1-2022/3/1 |
| NCT03812705 | Fecal microbiota transplantation for steroid resistant/dependent acute GI GVHD | FMT | To evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal GVHD. | Single group assignment Open label |
II | 30 | 2018/12/13-2022/12/31 |
| NCT04269850 | Fecal microbiota transplantation with Ruxolitinib and Steroids as an upfront treatment of severe acute intestinal GVHD | FMT; Ruxolitinib; Methylprednisone |
To evaluate this combination treatment in the first line with FMT. | Single group assignment Open label |
I/II | 20 | 2019/9/1-2023/9/1 |
| NCT03371667 | To compare the efficacy of the addition of Methotrexate (MTX) to current standard acute GVHD first-line treatment with corticosteroids | Methotrexate | To compare the efficacy of the addition of MTX to current standard acute GVHD first-line treatment with corticosteroids. | Randomized Multicenter Double blinded Parallel assignment |
III | 102 | 2018/8/16-2021/9 |
| NCT03727113 | Optimization of antibiotic treatment in hematopoietic stem cell receptors | Antibiotics | To demonstrate that in ASCT receptors a predefined protocol of optimization of the antibacterial treatment will preserve the intestinal microbiota diversity which will correlate with decrease incidence of acute GVHD. | Observational Case-Control Prospective |
Unknown | 180 | 2018/1/16-2020/5/31 |
| NCT03727113 | Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant | Piperacillin-tazobactam | To compare the effects of different antibiotics on the community of friendly bacteria in the gut | Randomized Parallel Assignment Open Label |
II | 144 | 2017/2/10-2021/2 |
| (not R) NCT04059757 |
Fecal microbiota transplantation for the treatment of gastrointestinal acute GVHD | FMT | To see the efficacy and what side effects are seen with FMT as a treatment for GVHD. | Single group assignment Open label |
II | 17 | 2020/7/1-2021/12 |
| NCT04280471 | Fecal microbiota transplantation for the treatment of severe acute gut Graft-Versus-Host Disease | FMT capsule | To explore side effects of using an investigational procedure (FMT) in treating patients with severe acute gut GVHD. | Single group assignment Open label |
I | 10 | 2020/6/30-2022/7/1 |
| NCT04139577 | FMT In high-risk acute GVHD after allo-HCT | FMT | To evaluate the effectiveness of Fecal Microbiota Transplant (FMT) treatment in high-risk acute GVHD. | Single group assignment Open label |
I | 11 | 2019/11-2023/5/1 |
| NCT03549676 | Fecal microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study | FMT | To evaluate safety and efficacy of FMT for the treatment of refractory GVHD of the gut. | Single group assignment Open label |
I | 15 | 2019/7/1-2020/12/31 |
| NCT03359980 | Treatment of steroid refractory gastro-intestinal acute GVHD after allogeneic HSCT With fecal microbiota transfer | FMT | To explore the employment of FMT in GI-aGVHD. | Single group assignment Open label |
II | 32 | 2018/8/13-2020/12 |
FMT, fecal microbiota transplantation; GI-aGVHD, gastrointestinal acute graft-versus-host disease.