Status:
NOT_YET_RECRUITING
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)
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Graft-Versus-Host Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 ...
Detailed Description
Study Design Overview: Ten patients aged \>50 years scheduled for haploidentical hematopoietic stem cell transplantation (HSCT) will be enrolled. Stool specimens will be collected from both patients ...
Eligibility Criteria
Inclusion
- Subjects eligible for this study must satisfy all of the following criteria:
- Age \>50 years, regardless of gender;
- Scheduled for haploidentical hematopoietic stem cell transplantation;
- ECOG performance status score ≤2;
- Voluntarily participate and provide written informed consent.
Exclusion
- Subjects presenting with any of the following conditions will be excluded from this study:
- Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);
- 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;
- Allergic or immune-mediated diseases:
- Autoimmune hepatitis, systemic lupus erythematosus (SLE), ankylosing spondylitis, immune-mediated osteoarthritis, allergic dermatitis, immune thrombocytopenic purpura (ITP);
- Antibiotic usage within 7 days prior to enrollment.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 4 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07188909
Start Date
September 15 2025
End Date
March 4 2026
Last Update
September 23 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China, 300020