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 | Not Yet Recruiting

• 1 other identifier: IIT2025086
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.

Conditions

Acute Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To study the changes of intestinal flora of subjects before and after taking probiotics from patients for 100 days

  within 100 days

Study Arms (1)

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.

Drug: Patient-Donor Derived Probiotics

Interventions

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.

Patient-Donor Derived Probiotics

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, 300020, China

Location

Central Study Contacts

Erlie Jiang, doctor

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

xin Chen

CONTACT

+86-13920985705; chenxin@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 23, 2025
• Study Start: September 15, 2025
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CN (1)