Study of Intestinal Microbiota Transplant to Improve Gut Health in Adults Undergoing Allogeneic Stem Cell Transplant for Blood Cancers

What this Trial Is About

Researchers are investigating the ability of intestinal microbiota transplantation IMT to restore healthier gut microbiota levels in patients with blood cancers who are scheduled for allogeneic stem cell transplant. This phase 2 clinical trial aims to compare the tolerability and acceptability of IMT capsules versus placebo, as well as assess changes in gut microbiome diversity and various health markers, including infection rates, graft-versus-host disease, and survival outcomes. The study is sponsored by Imperial College London and focuses on patients with specific blood cancers such as acute lymphoblastic leukemia and myelodysplastic syndrome. Participants will be randomly assigned to one of two groups. One group will swallow 10 IMT capsules containing viable microorganisms approximately two weeks before their stem cell transplant, while the other group will receive 10 placebo capsules with inactive ingredients that look identical to the IMT capsules. Both treatments are given once at the second study visit, maintaining blinding. The trial compares the effects of these capsules on gut microbiota diversity and clinical outcomes. Participants will provide stool, urine, and blood samples during scheduled visits before and up to one year after transplant. They will also complete questionnaires about their health and treatment experience. Researchers will monitor multiple measures, including gut microbiome diversity at many time points, infection occurrences, quality of life, organ function, and graft-versus-host disease severity. Follow-up assessments extend up to 365 days post-transplant to track overall survival and other health outcomes.

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial