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Ontogeny of MAIT Cells in Neonates and Hematopoietic Stem Cell Transplant Recipients (NEOMAIT)

2023年2月2日 更新者:Assistance Publique - Hôpitaux de Paris
The objective of this study is 1/ to determine the rate and kinetics of MAIT cell expansion and maturation in neonates in relation with gestational age, and in HSCT recipient children in relation with the source of donor stem cells, 2/ to correlate gut microbiota diversity and function with MAIT cell maturation and function in neonates and HSCT recipients; and 3/ to link MAIT cells and gut microbiota composition with microbial infections and severe intestinal inflammatory events in term and preterm neonates, and in HSCT recipients

研究概览

详细说明

The mucosa-associated invariant T (MAIT) cells are innate-like T cells with restricted T cell receptor (TCR) usage, which are preferentially localized in mucosal tissues and respond to microbial infection by rapidly producing cytokines and cytotoxic effectors. They recognize the non-classical related molecule (MR1). MAIT cells react against a newly identified class of antigens presented by MR1: Riboflavin (Rib) precursors, which are found in most bacteria and yeasts. Currently, very little is known about the ontogeny of MAIT cells in the human, because of the difficulty to follow longitudinally their development. Cross-sectional studies have identified only the initial (cord blood) and final (adult subjects) steps of human MAIT cell maturation program. Moreover, there are no data on relationships between human MAIT cell expansion and maturation, and gut microbiota development. Given the potential importance of MAIT cells in protection from microbial infections at epithelial surfaces, we will investigate the maturation dynamics of MAIT cells in relation with gut microbiota diversity and function in two clinical settings characterized by a high predisposition to severe microbial infections before the establishment of protective adaptive immunity, namely i/ the neonatal period and ii/ the early immune reconstitution period following allogeneic hematopoietic stem cell transplantation (HSCT) in children. Our study will combine multiparametric phenotypic and functional characterization of MAIT cells with the use of new molecular microbiota analytic methodology (high throughput sequencing, metagenomics, Rib microbiology) to determine how the presence or functionality of MAIT cells is influenced by the gut microbiota.

Our consortium is composed of three independent research teams, experts in innate immunity, microbial ecology and MAIT cell biology, three independent clinical teams providing exceptional resources to patient samples, and one team providing expertise for methodology and statistical analysis. Their synergistic interaction will offer the various complementary expertise that is necessary for this project.

This project will decipher how MAIT cell numbers or functions are influenced by the gut microbiota composition, and reciprocally, how MAIT cells regulate or control expansion of gut microbiota components competing with opportunistic or pathogenic bacteria or responsible for infections. Ultimately, this study will determine how and when gut microbiota and MAIT cell interactions are involved in the control of severe infectious or intestinal inflammatory events in high risk infants, an indispensable step to design predictive biomarkers and ultimately propose new therapeutic options.

研究类型

观察性的

注册 (实际的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Paris、法国、75019
        • Hopital Robert Debre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1天 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

newborns hospitalized in the Neonatal Intensive Care Unit of the Hospital Robert Debré and grafted children hospitalized in the Hematology-Immunology Pediatric Service of the Hospital Robert Debré

描述

Inclusion Criteria:

  • neonates 24-41 weeks gestational age
  • hematopoietic stem cell transplant recipient children (< 18 years old, donor source: cord blood or genoidentical donor)

Exclusion Criteria:

  • neonates : chromosomal abnormalities detected before birth
  • source of HSCT: phenol-identical donors

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
neonates
neonates 24-41 weeks gestational age
Tubes fund recovery of blood counts among newborns
children
hematopoietic stem cell transplant recipient children (< 18 years old, donor source: cord blood or genoidentical donor)
blood samples on the recovery kinetics after transplant. The rest of the blood test and stool sample done as part of a routine examination.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
MAIT cell numbering neonates after birth
大体时间:to 60days
Absolute number, percentage and phenotype of MAIT cells by flow cytometry in the circulating blood after birth according to gestational age and / or maternal-fetal infections (IMF), or after allogeneic HSCT according to the origin of HSCs.
to 60days

次要结果测量

结果测量
措施说明
大体时间
Absolute number of MAIT
大体时间:to 60days
Absolute number and percentage of MAIT among mothers of infants on the day of delivery and in geno-identical donors before transplantation.
to 60days
Absolute number of other immune cell populations
大体时间:to 60 days
Absolute number and percentage of other immune cell populations by flow cytometry on the same blood samples.
to 60 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年3月1日

初级完成 (实际的)

2018年2月1日

研究完成 (实际的)

2018年2月1日

研究注册日期

首次提交

2015年3月6日

首先提交符合 QC 标准的

2015年3月25日

首次发布 (估计)

2015年3月31日

研究记录更新

最后更新发布 (实际的)

2023年2月3日

上次提交的符合 QC 标准的更新

2023年2月2日

最后验证

2018年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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