Microbiome Alterations in IL10RA-deficient Patients After HSCT

NCT03752372 | Terminated

• 1 other identifier: HSCT microbiomte
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Microbiota

Keywords

interleukin 10 receptor alpha gene

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Escherichia - Shigella

  describe the microbiome at the genus level

  during the hospitalization of each eligible patient, an average of 90 days per patient

Secondary Outcomes (6)

• chimerism

  during the hospitalization of each eligible patient, an average of 90 days per patient

• manifestation of graft-versus-host disease

  during the hospitalization of each eligible patient, an average of 90 days per patient

• Sobs indices

  during the hospitalization of each eligible patient, an average of 90 days per patient

• Chao1 estimator

  during the hospitalization of each eligible patient, an average of 90 days per patient

• neutrophil cell count

  during the hospitalization of each eligible patient, an average of 90 days per patient

Other Outcomes (3)

• relative abundance of Clostridiales

  during the hospitalization of each eligible patient, an average of 90 days per patient

• Shannoneven indices

  during the hospitalization of each eligible patient, an average of 90 days per patient

• Simpsoneven indices

  during the hospitalization of each eligible patient, an average of 90 days per patient

Study Arms (1)

HSCT cohort

IL10RA-deficient patients who received hematopoietic stem cell transplantation

Procedure: hematopoietic stem cell transplantation

Interventions

hematopoietic stem cell transplantation PROCEDURE

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

HSCT cohort

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with IL10RA deficiency and who received the hematopoietic stem cell transplantation in a tertiary hospital were enrolled.

You may qualify if:

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

You may not qualify if:

• Unwilling to participate.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

Related 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 Bowel Dis. 2018 Jun 8;24(7):1416-1427. doi: 10.1093/ibd/izy028.

  PMID: 29788474 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Inflammatory Bowel Disease 28, Autosomal Recessive

Interventions

Hematopoietic Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Ying Huang, MD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of gastroenterology of Children's Hospital of Fudan University

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 26, 2018
• Study Start: October 1, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)