Table 8.
Clinical trials with microbiota-based interventions in HCT patients
| Name | Comparison | Outcomes | Study type | Clinical Trials.gov ID |
Status |
|---|---|---|---|---|---|
| Dietary Interventions | |||||
| Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS | Standard hospital neutropenic diet vs. diet inclusive of fresh fruits and vegetables | Incidence of major infections | Randomized open-label | NCT03016130 | Recruiting |
| Gluten Free Diet in Preventing GVHD in Patients Undergoing HCT | Gluten-free diet | GVHD | Single-arm | NCT03102060 | Recruiting |
| Randomized, Prospective, Multicenter Study to Compare Enteral Nutrition to Parenteral Nutrition as Feeding Support in Patients With Hematologic Malignancies Undergoing Allo-HCT | Enteral vs. intravenous nutrition | Mortality | Randomized open-label | NCT01955772 | Recruiting |
| Donor Human Milk in Young Children Receiving Bone Marrow Transplantation | Enteral donor breastmilk vs. standard diet | Percentage of stool Lactobacillales | Randomized open-label | NCT02470104 | Active, not recruiting |
| Prebiotic and Probiotic Interventions | |||||
| Modification of the Intestinal Microbiome by Diet Intervention to Mitigate Acute GVHD | Bob’s Red Mill potato-starch-based prebiotic vs. standard diet | GVHD | Randomized open-label | NCT02763033 | Not yet open |
| Fructo-oligosaccharides in Treating Patients with Blood Cancer Undergoing HCT | FOS | Prebiotic tolerability | Single-arm | NCT02805075 | Recruitment completed |
| Lactobacillus rhamnosus GG in Reducing Incidence of GVHD in Patients Who Have Undergone HCT | Lactobacillus rhamnosus GG supplementation vs. control | GVHD | Randomized open-label | NCT02144701 | Active, not recruiting |
| Fecal Microbiota Transplantation | |||||
| Auto-FMT for Prophylaxis of CDI in Recipients of Allo-HCT | Auto-FMT vs. control | CDI | Randomized open-label | NCT02269150 | Recruiting |
| Fecal Transplant for Steroid-Resistant and Steroid-Dependent Gut Acute GVHD | Fecal microbiota transplant | Safety, GVHD | Single-arm | NCT03214289 | Recruiting |
| Antibiotic Interventions | |||||
| Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of HCT | Piperacillin-tazobactam vs. Cefepime during febrile neutropenia | Change in Clostridial abundance | Randomized open-label | NCT03078010 | Recruiting |
| Gut Decontamination in Pediatric Allo-HCT | Oral Vancomycin-Polymixin B vs. standard of care | Intestinal microbiota diversity | Randomized open-label | NCT02641236 | Recruiting |