Faecal Microbiota Transplantation After Allogeneic Stem Cell Transplantation

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Jun 15, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called Fecal Microbiota Transplantation (FMT) to help prevent complications in patients who have received a special type of blood stem cell transplant, known as allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main goal is to see if FMT can reduce the risk of a serious condition called Graft versus Host Disease (GvHD), which can occur after the transplant. The study is currently looking for participants aged 18 and older, including both men and women, who are undergoing this transplant for specific blood-related cancers or disorders.

If you or a loved one is considering participation, you should know that participants must be in remission from their disease and not have any serious uncontrolled health issues. Those who join the study will provide signed consent and will be monitored closely throughout the process to see how well the treatment works. It's important to note that individuals with certain medical histories or conditions, like active cancer or severe health problems, are not eligible to participate. This trial is an opportunity to contribute to important research that could improve the care and outcomes for patients undergoing stem cell transplants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient aged 18 or over
• • Men and women
• • Patients affiliated with a social-security organization
• • Patients undergoing a myelo-ablative allo-HSCT for a controlled haematologic malignant disease, with peripheral stem cells, whatever the type of donor (except cord blood)
• • Signed and dated informed consent
• Exclusion Criteria:
• • Status of tumor progression at the time of allo-HSCT
• • Inability to understand the protocol (linguistic barrier, cognitive difficulties)
• • Medical history of another progressive cancer or occurrence in the 3 previous years (excluding basal cell carcinoma)
• • Presence of a simultaneous serious and uncontrolled disease (severe cardiac, renal, hepatic or respiratory failure, severe sepsis)
• • Fecal incontinence
• • Participation in another clinical trial studying an allograft procedure including the type of graft, the type of immunosuppression, a preventive or a curative treatment of GvHD, or studying the effectiveness of a FMT in another indication.
• • Pregnant women
• • Patient under guardianship, curatorship or protection of justice