Fecal Microbiota Transplantation for Steroid-resistant or Relapsed Immune Thrombocytopenia (NCT07733037) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Fecal Microbiota Transplantation for Steroid-resistant or Relapsed Immune Thrombocytopenia
China42 participantsStarted 2026-01-10
Plain-language summary
This is a randomized, double-blind, placebo-controlled phase 2 trial to evaluate the safety and efficacy in immune thrombocytopenia patients receiving fecal microbiota transplantation
Who can participate
Age range
18 Years – 70 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
. Aged 18 to 70 years, regardless of gender.
. Patients diagnosed with immune thrombocytopenia (ITP) in line with the diagnostic criteria, and with a disease course of ≥ 12 months (chronic ITP).
. 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).
. Sustained platelet count \< 30×10⁹/L during the screening period.
. Subjects voluntarily participate in this study and sign a written informed consent form.
Exclusion criteria
. Secondary thrombocytopenia caused by other factors, such as drug-induced etiology, infection-related conditions, or other autoimmune diseases (e.g., systemic lupus erythematosus).
. 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).
. Active infection or receipt of systemic antibiotic therapy within the past 4 weeks.
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
Overall Response Rate (ORR) at Week 12 of Treatment
Timeframe: Week 12 (±7 days) after the initiation of treatment
. 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).
. A history of malignant tumors or primary immunodeficiency diseases.
. Pregnant or lactating women.
. Previous splenectomy, rituximab therapy, or plasma exchange treatment within the past 3 months.
. Other conditions deemed inappropriate for study participation by the investigators based on clinical judgment.