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Safety and Feasibility of FMT for Immune Recovery After HSCT

NCT07755319 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Humoral Immunodeficiency
  • Hematopoietic Stem Cell Transplantation

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755319 on ClinicalTrials.gov