Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)
Institute of Hematology & Blood Diseases Hospital, China
Phase
Not applicable
Started
2025-09-15
Last updated
2025-09-23
Condition(s) studied
Acute Graft-Versus-Host Disease
Investigational drug(s) / intervention(s)
Patient-Donor Derived Probiotics
Patient-Donor Derived Probiotics: To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
Study summary
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Subjects eligible for this study must satisfy all of the following criteria:
1. Age \>50 years, regardless of gender;
2. Scheduled for haploidentical hematopoietic stem cell transplantation;
3. ECOG performance status score ≤2;
4. Voluntarily participate and provide written informed consent.
Exclusion Criteria:
Subjects presenting with any of the following conditions will be excluded from this study:
1. Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);
2. Gastrointestinal disorders:
* Clostridioides difficile infection (CDI): Recurrent or refractory CDI;
* Other conditions: Ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS), diarrhea associated with dysbiosis, liver cirrhosis;
3. Allergic or immune-mediated diseases:
Autoimmune hepatitis, systemic lupus erythematosus (SLE), ankylosing spondylitis, immune-mediated osteoarthritis, allergic dermatitis, immune thrombocytopenic purpura (ITP);
4. Antibiotic usage within 7 days prior to enrollment.
Primary outcome measure(s)
Clinical response rate of intestinal acute graft-versus-host disease (aGVHD) — within 100 days Changes of stool frequency of subjects before and after taking probiotic capsules from patients.
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
Tianjin Municipality
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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