Inflammatory Bowel Diseases, Microbiota
Conditions
Keywords
interleukin 10 receptor alpha gene
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.
Interventions
1. Reduced intensity conditioning(RIC) chemotherapy regimen before transplantation 2. All patients were cared for in single rooms ventilated with a highly effective particulate air filtration system. All patients received intravenous immunoglobulin and antimicrobial prophylaxis, which included antiviral, antifungal, and Pneumocystis jirovecii prophylaxis with ganciclovir and micafungin, as per routine clinical practice before transplantation. 3. Umbilical cord blood transplantation
Sponsors
Study design
Eligibility
Inclusion criteria
* IL10RA gene mutations; * Eligible for hematopoietic stem cell transplantation.
Exclusion criteria
* Unwilling to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Escherichia - Shigella | during the hospitalization of each eligible patient, an average of 90 days per patient | describe the microbiome at the genus 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neutrophil cell count | during the hospitalization of each eligible patient, an average of 90 days per patient | blood test results |
| 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 \[0,100%\] |
| 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 |
| Sobs indices | during the hospitalization of each eligible patient, an average of 90 days per patient | describe the the observed richness of each sample |
| 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 |
| platelet count | during the hospitalization of each eligible patient, an average of 90 days per patient | blood test results |
Other
| Measure | Time frame | Description |
|---|---|---|
| relative abundance of Clostridiales | during the hospitalization of each eligible patient, an average of 90 days per patient | describe the microbiome at the order level |
| Simpsoneven indices | during the hospitalization of each eligible patient, an average of 90 days per patient | measure community evenness, scale ranges \[0,1\]; higher values represent a better outcome |
| Shannoneven indices | during the hospitalization of each eligible patient, an average of 90 days per patient | measure the community evenness, scale ranges \[0,1\]; higher values represent a better outcome |
Countries
China