Using autologous fecal bacteria to prevent acute graft versus host disease
Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study
This study is testing if using a patient's own gut bacteria can help prevent acute graft versus host disease after they receive a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT04745221 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of autologous fecal microbiota transplantation (FMT) in preventing acute graft versus host disease (aGVHD) in patients undergoing haploidentical hematopoietic stem cell transplantation. The approach involves administering the patient's own fecal bacteria to potentially enhance gut microbiome diversity and improve outcomes post-transplant. Participants are carefully selected based on specific inclusion and exclusion criteria to ensure the safety and relevance of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are haplo-HSCT patients with specific gut microbiome characteristics.
Not a fit: Patients over 60 years old, under 10 years old, or those with gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of aGVHD in bone marrow transplant patients.
How similar studies have performed: While the use of fecal microbiota transplantation is gaining interest, this specific application in preventing aGVHD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Haplo-HSCT patients; Bacteroidetes \>0.1%; inverse Simpson diversity ≥2 Exclusion Criteria: * Gastrointestinal diseases；Age\>60; or Age\<10；Probiotics or prebiotics were taken before enrollment
Where this trial is running
Suzhou, Jiangsu
- Ye Zhao — Suzhou, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.