Table 1.
Manipulation of the gut microbiome to enhance responses to cancer immunotherapy.
| Trial Number | Patient population | Intervention | Outcome(s) | Status |
|---|---|---|---|---|
| NCT02843425 | All cancer patients treated at MDACC | Addition of ½ cup beans per day to regular diet in a cross-over design |
Primary: Change in fecal microbiome profile from baseline (via 16S profiling) |
Open and recruiting (MDACC) |
| NCT02079662 | Stages II and III breast cancer patients treated at MDACC ages 18+ | Randomized intensive lifestyle change (Diet, exercise, psychosocial) |
Primary: Disease-free survival (DFS) Secondary: Change in fecal and oral microbiome (via 16S profiling) |
Open and recruiting (MDACC) |
| NCT01895530 | CRC patients ages 18+ undergoing elective CRC resection | Randomized probiotic (S. Boulardii) administration |
Primary: Cytokine expression in colonic mucosa (via qPCR) Secondary: Postoperative complications |
Completed (Consoli et al., 2016) |
| NCT03072641 | CRC patients ages 18+ | Randomized probiotic (ProBion Clinica B. lactis Bl-04, L.acidophilus NCFM + Inulin) administration |
Primary: Change in fecal and tumor microbiota from baseline Secondary: Changes in epigenetic patterns of tumor tissue from baseline |
Completed(Hibberd et al., 2017) |
| NCT03358511 | Postmenopausal breast cancer patients stages I–III | Single arm probiotic (Primal Defense Ultra multi-strain probiotic formula) administration |
Primary: Change in mean number of CD8+ cells from baseline |
Open and recruiting (Mayo Clinic) |
| NCT02928523 | Acute myeloid leukemia patients ages 18–65 treated with intensive chemo and antibiotics | Single arm autologous FMT (frozen inoculum) |
Primary: Diversity of the gut microbiome, multi-drug resistant bacteria eradication Secondary: Signature of dysbiosis of gut microbiome |
Ongoing, closed to recruiting (France) |
| NCT03353402 | Metastatic melanoma patients ages 18+ who previously failed standard therapies | Single arm FMT (colonoscopy or gastroscopy) from patient donors who responded to immunotherapy |
Primary: Safety (AEs associated with FMT), engraftment of FMT Secondary: Changes in immune cell populations and activity, objective response rate |
Open and recruiting (Israel) |