Table 1 ∣.
Summary of ongoing clinical trials investigating microbial interventions in allo-HSCT
| Trial title | Aims and interventions | Phase | Trial number | Refs |
|---|---|---|---|---|
| Antibiotic treatment and its impact on microbiota | ||||
| Gut decontamination in paediatric allo-HSCT | To study the effect of vancomycin–polymyxin B treatment on patient flora and on GVHD and survival | II | NCT02641236 | 101 |
| Choosing the best antibiotic to protect friendly gut bacteria during the course of stem cell transplant | To compare the effect between piperacillin–tazobactam and cefepime on patient flora (7 ± 2 days after initiation of antibiotics) | II | NCT03078010 | 89 |
| Strategies for GVHD treatment | ||||
| Medical home care for HSC transplantation | To compare the incidence of acute grade II–IV GVHD between patients receiving patient-centred medical home care and those receiving standard hospital care | II | NCT02218151 | 131 |
| Study of IL-22 IgG2-Fc (F-652) for subjects with grade II–IV lower GI acute GVHD | To examine combination treatment with corticosteroid for new-onset grade II–IV GVHD in the lower GI tract | I/II | NCT02406651 | 65 |
| Lactobacillus rhamnosus str. GG in reducing incidence of GVHD in patients who have undergone donor stem cell transplant | To study the impact of Lactobacillus rhamnosus str.GG on reducing incidence of GVHD | Pilot | NCT02144701 | 133 |
| Fructooligosaccharides in treating patients with blood cancer undergoing donor stem cell transplant | To study side effects and best dose of fructooligosaccharides for potential use for GVHD treatment | I | NCT02805075 | 123 |
| Modification of the intestinal microbiome by diet intervention to mitigate acute GVHD | To study the effect of potato-based starch on butyrate production and rates of acute GVHD | II | NCT02763033 | 124 |
| Gluten-free diet in preventing GVHD in patients undergoing donor stem cell transplant | To evaluate the impact of gluten-free diet on GVHD prophylaxis | Pilot | NCT03102060 | 168 |
| FMT trials | ||||
| Autologous FMT for prophylaxis of Clostridium difficile infection in recipients of allo-HSCT | To restore diversity and prevent Clostridium difficile infection during allo-HSCT | II | NCT02269150 | 34 |
| FMT after HSC transplantation | To assess the feasibility of empiric FMT soon after allo-HSCT; secondary outcome measures include GVHD and survival | Early I | NCT02733744 | 129 |
| Stool transplantation to reduce antibiotic-resistance transmission (START) | To investigate the outcomes of FMT aiming at eradicating gut colonization with multidrug-resistant bacteria in patients with blood disorders | NA | NCT02461199 | 169 |
| Nutrition and transplant outcome | ||||
| Randomized prospective multicentre study to compare enteral nutrition with parenteral nutrition as feeding support in patients presenting with malignant haemopathy who underwent an allogeneic HSC transplantation (NEPHA) | To compare between enteral nutrition and parenteral nutrition groups after myeloablative allo-HSCT; occurrence of transplant-related mortality, GVHD and infections will be assessed | III | NCT01955772 | 166 |
Allo-HSCT, allogeneic haematopoietic stem cell transplantation; FMT, faecal microbiota transplantation; GI, gastrointestinal; GVHD, graft-versus-host disease; HSC, haematopoietic stem cell; IL-22, interleukin-22; NA, not available.