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Microbiome Alterations in IL10RA-deficient Patients After HSCT

Longitudinal Development of Intestinal Microbiome in IL10RA-deficient Patients After Hematopoietic Stem Cell Transplantation

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03752372
Enrollment
13
Registered
2018-11-26
Start date
2017-10-01
Completion date
2020-02-28
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Microbiota

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

PROCEDUREhematopoietic stem cell transplantation

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

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* IL10RA gene mutations; * Eligible for hematopoietic stem cell transplantation.

Exclusion criteria

* Unwilling to participate.

Design outcomes

Primary

MeasureTime frameDescription
Clostridium sensus_stricto_1during the hospitalization of each eligible patient, an average of 90 days per patientdescribe the microbiome at the genus level
relative abundance of Firmicutesduring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the microbiome at the phylum level
Escherichia - Shigelladuring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the microbiome at the genus level
Shannon indicesduring the hospitalization of each eligible patient, an average of 90 days per patientShannon index is a popular diversity index in the ecological literature; minimum score is zero, higher values represent a better outcome
Simpson indicesduring the hospitalization of each eligible patient, an average of 90 days per patientSimpson 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 Proteobacteriaduring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the microbiome at the phylum level

Secondary

MeasureTime frameDescription
neutrophil cell countduring the hospitalization of each eligible patient, an average of 90 days per patientblood test results
chimerismduring the hospitalization of each eligible patient, an average of 90 days per patientThe level of chimerism of each patient will be reported as percentages \[0,100%\]
manifestation of graft-versus-host diseaseduring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the graft-versus-host disease happened to each patient
Sobs indicesduring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the the observed richness of each sample
Chao1 estimatorduring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the operational taxonomic unit(OTU) numbers of each sample
platelet countduring the hospitalization of each eligible patient, an average of 90 days per patientblood test results

Other

MeasureTime frameDescription
relative abundance of Clostridialesduring the hospitalization of each eligible patient, an average of 90 days per patientdescribe the microbiome at the order level
Simpsoneven indicesduring the hospitalization of each eligible patient, an average of 90 days per patientmeasure community evenness, scale ranges \[0,1\]; higher values represent a better outcome
Shannoneven indicesduring the hospitalization of each eligible patient, an average of 90 days per patientmeasure the community evenness, scale ranges \[0,1\]; higher values represent a better outcome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026