Microbiome Alterations in IL10RA-deficient Patients After HSCT

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03752372
• Other study ID #: HSCT microbiomte
• Status: Terminated
• Start date: October 1, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: August 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria:

• IL10RA gene mutations;

• Eligible for hematopoietic stem cell transplantation.

Exclusion Criteria:

• Unwilling to participate.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Microbiota

Intervention

Procedure:
• hematopoietic stem cell transplantation
Reduced intensity conditioning(RIC) chemotherapy regimen before transplantation 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. Umbilical cord blood transplantation

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Peng K, Qian X, Huang Z, Lu J, Wang Y, Zhou Y, Wang H, Wu B, Wang Y, Chen L, Zhai X, Huang Y. Umbilical Cord Blood Transplantation Corrects Very Early-Onset Inflammatory Bowel Disease in Chinese Patients With IL10RA-Associated Immune Deficiency. Inflamm B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	relative abundance of Clostridiales	describe the microbiome at the order level	during the hospitalization of each eligible patient, an average of 90 days per patient
Other	Shannoneven indices	measure the community evenness, scale ranges [0,1]; higher values represent a better outcome	during the hospitalization of each eligible patient, an average of 90 days per patient
Other	Simpsoneven indices	measure community evenness, scale ranges [0,1]; higher values represent a better outcome	during the hospitalization of each eligible patient, an average of 90 days per patient
Primary	Shannon indices	Shannon index is a popular diversity index in the ecological literature; minimum score is zero, higher values represent a better outcome	during the hospitalization of each eligible patient, an average of 90 days per patient
Primary	Simpson indices	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	during the hospitalization of each eligible patient, an average of 90 days per patient
Primary	relative abundance of Proteobacteria	describe the microbiome at the phylum level	during the hospitalization of each eligible patient, an average of 90 days per patient
Primary	relative abundance of Firmicutes	describe the microbiome at the phylum level	during the hospitalization of each eligible patient, an average of 90 days per patient
Primary	Clostridium sensus_stricto_1	describe the microbiome at the genus level	during the hospitalization of each eligible patient, an average of 90 days per patient
Primary	Escherichia - Shigella	describe the microbiome at the genus level	during the hospitalization of each eligible patient, an average of 90 days per patient
Secondary	chimerism	The level of chimerism of each patient will be reported as percentages [0,100%]	during the hospitalization of each eligible patient, an average of 90 days per patient
Secondary	manifestation of graft-versus-host disease	describe the graft-versus-host disease happened to each patient	during the hospitalization of each eligible patient, an average of 90 days per patient
Secondary	Sobs indices	describe the the observed richness of each sample	during the hospitalization of each eligible patient, an average of 90 days per patient
Secondary	Chao1 estimator	describe the operational taxonomic unit(OTU) numbers of each sample	during the hospitalization of each eligible patient, an average of 90 days per patient
Secondary	neutrophil cell count	blood test results	during the hospitalization of each eligible patient, an average of 90 days per patient
Secondary	platelet count	blood test results	during the hospitalization of each eligible patient, an average of 90 days per patient