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Safety and Feasibility of FMT for Immune Recovery After HSCT
Sponsor: The First Affiliated Hospital of Soochow University
Summary
Patients who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) often experience slow and incomplete recovery of their immune system, particularly the part responsible for producing antibodies (humoral immunity). This can lead to increased risk of infections and other complications. Previous studies suggest that the gut microbiome and its metabolites, such as short-chain fatty acids (propionate and butyrate), play a critical role in immune recovery. This study has two phases. In the first phase, we will observe changes in immune function, lymphocyte subsets, and gut metabolites (propionate and butyrate) before and at 1, 3, and 6 months after transplantation in 50-80 patients. We will compare patients with severe immune deficiency to those with normal recovery to identify differences in gut bacteria and metabolites. In the second phase, we will perform selective fecal microbiota transplantation (FMT) in 6 patients who still have severe humoral immunodeficiency at 6 months post-transplant. The FMT capsules will be specially selected from donors whose gut bacteria are rich in both propionate-producing and butyrate-producing strains. Patients will receive 20 capsules daily for 3 consecutive days (60 capsules total). We will evaluate the safety and feasibility of this approach, and observe whether fecal secretory immunoglobulin A (sIgA) shows signs of recovery at 3 months after FMT. The study is expected to take approximately 2 years to complete. Findings may provide a new precision microbiome-based strategy to promote immune recovery after transplantation.
Official title: Safety and Feasibility of Selective Fecal Microbiota Transplantation (FMT) for Immune Reconstitution in Immunodeficient Patients After Hematopoietic Stem Cell Transplantation (HSCT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2026-08-01
Completion Date
2028-10-31
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
Fecal microbiota transplantation (FMT)
The FMT capsules are prepared from healthy donor feces screened according to international consensus guidelines. Oral administration of human-derived gut microbiota capsules, each containing no fewer than 2×10¹¹ organisms, given at a dose of 20 capsules per day for 3 consecutive days (total 60 capsules per course).No dose adjustments will be made during the study. The total treatment duration is 3 days. This is a single-arm, open-label, phase I/IIa proof-of-concept safety exploratory trial. Participants will be followed for 3 months post-FMT to assess safety, feasibility, and preliminary biological signals of immune recovery.
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China