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)

NCT07188909 · tracked via the Priya Life Science China tracker

Sponsor

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

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

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Official registry record

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.

View NCT07188909 on ClinicalTrials.gov ↗ ← All trials in China