About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);
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;
Antibiotic usage within 7 days prior to enrollment.
Trial design
Single group
Treatments tested in this trial
Patient-Donor Derived Probiotics
DrugTo 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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