Microbiome Alterations in IL10RA-deficient Patients After HSCT

August 10, 2020 updated by: Ying HUANG, Children's Hospital of Fudan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwilling to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HSCT cohort
IL10RA-deficient patients who received hematopoietic stem cell transplantation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shannon indices
Time Frame: 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
during the hospitalization of each eligible patient, an average of 90 days per patient
Simpson indices
Time Frame: 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
during the hospitalization of each eligible patient, an average of 90 days per patient
relative abundance of Proteobacteria
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
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
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
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
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the genus level
during the hospitalization of each eligible patient, an average of 90 days per patient
Escherichia - Shigella
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the genus level
during the hospitalization of each eligible patient, an average of 90 days per patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
chimerism
Time Frame: 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%]
during the hospitalization of each eligible patient, an average of 90 days per patient
manifestation of graft-versus-host disease
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the graft-versus-host disease happened to each patient
during the hospitalization of each eligible patient, an average of 90 days per patient
Sobs indices
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the the observed richness of each sample
during the hospitalization of each eligible patient, an average of 90 days per patient
Chao1 estimator
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the operational taxonomic unit(OTU) numbers of each sample
during the hospitalization of each eligible patient, an average of 90 days per patient
neutrophil cell count
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
blood test results
during the hospitalization of each eligible patient, an average of 90 days per patient
platelet count
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
blood test results
during the hospitalization of each eligible patient, an average of 90 days per patient

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
relative abundance of Clostridiales
Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient
describe the microbiome at the order level
during the hospitalization of each eligible patient, an average of 90 days per patient
Shannoneven indices
Time Frame: 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
during the hospitalization of each eligible patient, an average of 90 days per patient
Simpsoneven indices
Time Frame: 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
during the hospitalization of each eligible patient, an average of 90 days per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ying Huang, MD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSCT microbiomte

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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