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Can gut bacteria help rebuild immunity after stem cell transplants?

NCT ID NCT07755319

Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This trial explores whether transplanting gut bacteria from healthy donors can help restore the immune system in people who have weak immunity after a stem cell transplant. The study first observes immune recovery in patients to identify those with severe deficiency, then gives a short course of specially selected fecal microbiota capsules to a small group. The goal is to see if this approach is safe and feasible, and whether it can improve antibody production.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fecal microbiota transplantation (FMT) capsules made from healthy donor stool, rich in propionate- and butyrate-producing bacteria.
What this could lead to
If successful, this could offer a new way to boost immune recovery after stem cell transplants, potentially reducing infections and other complications.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not be conclusive. There are also risks of side effects, including infections or worsening of graft-versus-host disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B cell deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic stem cell transplantation Humoral immunodeficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

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