Microbiome Alterations in IL10RA-deficient Patients After HSCT
- Conditions
- MicrobiotaInflammatory Bowel Diseases
- Interventions
- Procedure: hematopoietic stem cell transplantation
- Registration Number
- NCT03752372
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
To elucidate the longitudinal development of intestinal microbiota in patients with IL10RA deficiency after hematopoietic stem cell transplantation (HSCT). The investigators planned to collect fecal samples from IL10RA-deficient patients who received HSCT. Samples were collected more than once every three days after engraftment in lamina flow ward and at least once a week before discharge. Microbial DNA was extracted from the fecal samples. And all analysis was based on the next generation sequencing data.
- Detailed Description
Hematopoietic stem cell transplantation is considered the only curative therapy for patients with interleukin-10 receptor-A(IL10RA) deficiency. The investigators aimed to collect the fecal samples of these patients throughout the conditioning, transplantation until discharge, providing a dense insight into the longitudinal development of intestinal microbiota.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
- IL10RA gene mutations;
- Eligible for hematopoietic stem cell transplantation.
- Unwilling to participate.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HSCT cohort hematopoietic stem cell transplantation IL10RA-deficient patients who received hematopoietic stem cell transplantation
- Primary Outcome Measures
Name Time Method Escherichia - Shigella during the hospitalization of each eligible patient, an average of 90 days per patient describe the microbiome at the genus level
relative abundance of Firmicutes during the hospitalization of each eligible patient, an average of 90 days per patient describe the microbiome at the phylum level
Shannon indices during the hospitalization of each eligible patient, an average of 90 days per patient Shannon index is a popular diversity index in the ecological literature; minimum score is zero, higher values represent a better outcome
Simpson indices during the hospitalization of each eligible patient, an average of 90 days per patient Simpson index in ecology is to measure the degree of concentration when individuals are classified into types; scale ranges \[0,1\]; lower values represent a better outcome
relative abundance of Proteobacteria during the hospitalization of each eligible patient, an average of 90 days per patient describe the microbiome at the phylum level
Clostridium sensus_stricto_1 during the hospitalization of each eligible patient, an average of 90 days per patient describe the microbiome at the genus level
- Secondary Outcome Measures
Name Time Method chimerism during the hospitalization of each eligible patient, an average of 90 days per patient The level of chimerism of each patient will be reported as percentages \[0,100%\]
Sobs indices during the hospitalization of each eligible patient, an average of 90 days per patient describe the the observed richness of each sample
platelet count during the hospitalization of each eligible patient, an average of 90 days per patient blood test results
Chao1 estimator during the hospitalization of each eligible patient, an average of 90 days per patient describe the operational taxonomic unit(OTU) numbers of each sample
manifestation of graft-versus-host disease during the hospitalization of each eligible patient, an average of 90 days per patient describe the graft-versus-host disease happened to each patient
neutrophil cell count during the hospitalization of each eligible patient, an average of 90 days per patient blood test results
Trial Locations
- Locations (1)
Children's hospital of Fudan university
🇨🇳Shanghai, Shanghai, China