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)

NCT ID: NCT07188909

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-03-04

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.

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 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:

1. Pre-collected patient and donor specimens will be homogenized

2. Target isolation and culture of core beneficial bacteria (Lactobacillus and Bifidobacterium)

3. Strain identification via TOF mass spectrometry

4. Fermentation and preparation of 200 enteric-coated capsules (100 Lactobacillus capsules + 100 Bifidobacterium capsules)

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.

Conditions

Acute Graft-Versus-Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient-Donor Derived Probiotics

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Erlie Jiang, doctor

Role: CONTACT

jiangerlie@ihcams.ac.cn

+86-15122538106

xin Chen

Role: CONTACT

chenxin@ihcams.ac.cn

+86-13920985705

Facility Contacts

Erlie Jiang

Role: primary

jiangerlie@ihcams.ac.cn

+86 22 23608600

Other Identifiers

IIT2025086

Identifier Type: -

Identifier Source: org_study_id