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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 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 and donors (due to frequent depletion of beneficial bacteria in such patients, donor specimens are essential to enhance probiotic detection and cultivation rates). Patient specimens will undergo 16S rDNA intestinal microbiome analysis.
Upon clinical diagnosis of intestinal aGVHD:
Post-intervention assessment (100 days after administration):
Changes in microbiome composition, relative abundance, species diversity, biochemical indicators, and bowel movement characteristics will be evaluated to assess the therapeutic efficacy of patient/donor-derived Lactobacillus and Bifidobacterium in GVHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-Donor Derived Probiotics | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Donor Derived Probiotics | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate of intestinal acute graft-versus-host disease (aGVHD) | Changes of stool frequency of subjects before and after taking probiotic capsules from patients. | within 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| To study the changes of intestinal flora of subjects before and after taking probiotics from patients for 100 days | 16SrDNA intestinal flora detection, to study the changes of Bifidobacterium, Lactobacillus and Clostridium before and after taking probiotics from patients for 100 days. | within 100 days |
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Inclusion Criteria:
Subjects eligible for this study must satisfy all of the following criteria:
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erlie Jiang, doctor | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn | |
| xin Chen | Contact | +86-13920985705 | chenxin@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | Tianjin Municipality | 300020 | China |
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