Safety and Feasibility of FMT for Immune Recovery After HSCT (NCT07755319) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety and Feasibility of FMT for Immune Recovery After HSCT
China86 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Receiving first allogeneic hematopoietic stem cell transplantation (allo-HSCT) with myeloablative or reduced-intensity conditioning
* Able to complete scheduled follow-up visits and sample collections
* Willing and able to provide written informed consent
For Phase 2 (FMT intervention): participants must additionally meet all of the following criteria at 6 months post-transplant:
* Serum IgA \< 0.07 g/L with IgG and IgM not yet recovered to normal range
* No active grade III-IV acute graft-versus-host disease (GVHD)
* Off systemic antibiotics for at least 2 weeks
* Willing to receive fecal microbiota transplantation (FMT) and sign dedicated informed consent for the intervention
Exclusion Criteria:
* Early post-transplant death or loss to follow-up
* Active grade III-IV acute GVHD (at time of screening)
* Continuous use of high-dose immunosuppressants (prednisone-equivalent dose \> 1 mg/kg/day)
* Refusal to participate or inability to comply with study procedures
For Phase 2 (FMT intervention): participants meeting any of the following criteria will be excluded from the FMT phase:
* Gastrointestinal obstruction, perforation, or severe intestinal dysfunction
* Severe cardiac, hepatic, or renal insufficiency that would preclude safe FMT administration
* Known allergy or hypersensitivity to any component of the FMT preparation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Endpoint of Safety and Feasibility of Selective FMT in Post-Allo-HSCT Patients
Timeframe: 3 months post-FMT
Trial details
NCT IDNCT07755319
SponsorThe First Affiliated Hospital of Soochow University