NCT03752372

Microbiome Alterations in IL10RA-deficient Patients After HSCT

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Day – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Microbiota

Interventions

Type	Name	Description
PROCEDURE	hematopoietic 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

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2018-11-26
• Last updated: 2020-08-12

Locations

1 site across 1 country: China