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Trial record 13 of 32 for:    Interleukin-10

Microbiome Alterations in IL10RA-deficient Patients After HSCT

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ClinicalTrials.gov Identifier: NCT03752372
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ying HUANG, Children's Hospital of Fudan University

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Microbiota Procedure: hematopoietic stem cell transplantation

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Development of Intestinal Microbiome in IL10RA-deficient Patients After Hematopoietic Stem Cell Transplantation
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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%]

  2. 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

  3. 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

  4. 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

  5. neutrophil cell count [ Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient ]
    blood test results

  6. platelet count [ Time Frame: during the hospitalization of each eligible patient, an average of 90 days per patient ]
    blood test results


Other Outcome Measures:
  1. 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

  2. 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

  3. 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


Biospecimen Retention:   Samples With DNA
Fecal samples


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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwilling to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752372


Contacts
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Contact: Aijuan Xue 18001691647 ajxue15@163.com

Locations
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China, Shanghai
Children's hospital of Fudan university Recruiting
Shanghai, Shanghai, China, 201102
Contact: Ying Huang, MD    13816882247    yhuang815@163.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Principal Investigator: Ying Huang, MD Children's Hospital of Fudan University

Publications of Results:
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Responsible Party: Ying HUANG, The director of gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03752372     History of Changes
Other Study ID Numbers: HSCT microbiomte
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ying HUANG, Children's Hospital of Fudan University:
interleukin 10 receptor alpha gene

Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases