drugset / Trial / NCT03862079

Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics

NCT03862079

RandomizedParallel-groupOpen-labelPrevention

Summary

This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics. Fecal microbiota transplantation is the administration by enema of fecal matter (stool) that includes helpful bacteria from a normal, healthy donor. Total gut decontamination uses antibiotics to remove/reduce the amount of bacteria in the digestive system. It is not yet known if a fecal microbiota transplant with or without total gut decontamination works better in preventing graft versus host disease compared to standard immunosuppressive therapies (therapies that lower the normal function of the immune system).

Timeline

Start
2020-06-01
Primary completion
2021-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified Oral
Subject Nystatin Unknown Oral