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Can a gut bacteria transplant help when steroids fail for a bleeding disorder?

NCT ID NCT07733037

Disease control Sponsor: Peking University People's Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether fecal microbiota transplantation (FMT) — transferring gut bacteria from a healthy donor — can help adults with chronic immune thrombocytopenia (ITP) whose disease has not responded to or has relapsed after steroid treatment. Participants will receive either FMT capsules or placebo capsules for six days. The study aims to see if FMT can safely raise platelet counts and improve disease control.

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) given as capsules
What this could lead to
If it works, this could offer a new treatment option for people with immune thrombocytopenia who do not respond to steroids.
What could go wrong
This is an early phase 2 trial with only 42 participants, so results may not apply broadly. FMT carries risks of infection or digestive side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

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

Started

Jan 2026

Expected to finish

Sep 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 to 70 years

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: 1. Aged 18 to 70 years, regardless of gender. 2. Patients diagnosed with immune thrombocytopenia (ITP) in line with the diagnostic criteria, and with a disease course of ≥ 12 months (chronic ITP). 3. Meeting the definitions of corticosteroid resistance or relapse (resistance: platelet count remains \< 30×10⁹/L despite treatment with standard-dose corticosteroids for ≥ 4 weeks; relapse: platelet count drops again to \< 30×10⁹/L after corticosteroid dose reduction or discontinuation). 4. Sustained platelet count \< 30×10⁹/L during the screening period. 5. Subjects voluntarily participate in this study and sign a written informed consent form. Exclusion Criteria: 1. Secondary thrombocytopenia caused by other factors, such as drug-induced etiology, infection-related conditions, or other autoimmune diseases (e.g., systemic lupus erythematosus). 2. Subjects positive for Helicobacter pylori (H. pylori) infection (rescreening is permitted only after completion of standard eradication therapy and a drug withdrawal period of at least 1 month). 3. Active infection or receipt of systemic antibiotic therapy within the past 4 weeks. 4. Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh Class C liver dysfunction, or estimated glomerular filtration rate \< 30 mL/min/1.73 m²). 5. A history of malignant tumors or primary immunodeficiency diseases. 6. Pregnant or lactating women. 7. Previous splenectomy, rituximab therapy, or plasma exchange treatment within the past 3 months. 8. Other conditions deemed inappropriate for study participation by the investigators based on clinical judgment.

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Conditions

The condition(s) this trial relates to.

Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

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

Immune thrombocytopenia (ITP)

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.