Fecal microbiota transplantation has demonstrated safety and efficacy in a new phase of clinical trials.

A recent study has demonstrated that fecal microbiota transplantation (FMT) is safe for preventing stem cell rejection in patients who have received them for blood cancer treatment. This represents another phase of clinical trials involving microbiome-based therapies from healthy individuals aimed at restoring bacterial communities in immunocompromised patients.

2025-01-30 10:01:35https://naked-science.ru/article/medicine/fecal-transplant-ii-phase

Researchers have published the results of the second phase of clinical trials on fecal microbiota transplantation (FMT) conducted at the Fred Hutchinson Cancer Center in the United States. The study continues to explore the role of the gut microbiome in the recovery of patients following stem cell transplantation.

Overall, the treatment must successfully complete three phases of clinical trials before it can receive approval and be used in medical practice. An article on this topic was published in the journal Nature Communications.

“The gut microbiome is an organ in its own right, closely linked to the immune system. The stem cell transplantation process damages the gut microbiome, and we want to see if FMT can help restore microbial diversity and promote the growth of beneficial bacteria that support a healthy immune system,” said lead author Dr. Armin Rashidi (Armin Rashidi).

The therapy was administered to 20 individuals who had undergone stem cell transplants from other donors. All patients were diagnosed with blood disorders, including cancer. Each received FMT three times a day for a week in the form of swallowable capsules. These contained a purified community of microorganisms sourced from stool samples of three healthy donors.

Based on the study’s results, researchers made three important conclusions. Firstly, the donor matters: the studies showed that the microbiome of the three donors integrated differently into the recipients' bodies. The microbiota from “donor #3” was successfully established in 67% of cases. This means that of all the microbes after FMT whose origins could be precisely identified, 67% were derived from the donor, while the rest were from the patient. The microbiome of the “successful” donor exhibited a high level of Bifidobacterium adolescentis.

Secondly, the diversity of the patient’s microbiota influences the success of the transplantation. Researchers believe that a less diverse gut environment before FMT may facilitate the engraftment of transplanted microbes.

Thirdly, FMT is safe. Microbiota transplantation is safe even for patients with significant immune deficiencies. The transfer of millions of live microbes to the patient did not cause any infections. Researchers linked this to the fact that these were “healthy” microbes from a healthy donor. The engraftment of the microbiome reached 100% for certain types of microbes.

The findings from this scientific work will be useful in a larger randomized study, for which patients are currently being actively recruited. This study aims to gather data on whether FMT improves treatment outcomes for patients who have undergone stem cell transplantation: specifically, whether it reduces hospitalizations, infections, and changes in quality of life and survival rates. A total of 126 patients will participate in the study.