Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04815811
Status:
UNKNOWN
Last Update Posted:
2021-03-25
First Post:
2020-10-21
Brief Title:
Study of the Sex Differences in Inflammatory Diseases in Children
Sponsor:
Queen Fabiola Childrens University Hospital
Organization:
Queen Fabiola Childrens University Hospital
Study Overview
Official Title:
Study of the Sex Differences in Inflammatory Diseases in Children
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SepsiX
Brief Summary:
Sexual differences in innate immune response have been demonstrated and were mainly attributed to the influence of the sex steroids 1-18 However recent clinical data revealed significant differences in inflammatory markers between boys and girls suffering from acute and chronic inflammatory diseases 19-23 Sex hormone levels in prepubertal children are particularly low and insufficient to explain the gender differences observed in inflammatory conditions from neonates to the elderly suggesting the contribution of another mechanism such as the influence of genes situated on the sex chromosomes and involved in the inflammatory response
The aim of this work is to evaluate the role of the X chromosome in the sex differences in inflammatory diseases in children In order to discriminate more precisely the role of the X chromosome relatively to the sex steroids in the sex-specific inflammatory response some innate immune functions related to X-linked genes will be evaluated in whole blood from prepubertal children of both sexes suffering from acute inflammatory processes such as pyelonephritis caused by Escherichia coli pneumonia with pleural effusion caused by Streptococcus pneumoniae or sepsis
The aim of this work is to evaluate the role of the X chromosome in the sex differences in inflammatory diseases in children In order to discriminate more precisely the role of the X chromosome relatively to the sex steroids in the sex-specific inflammatory response some innate immune functions related to X-linked genes will be evaluated in whole blood from prepubertal children of both sexes suffering from acute inflammatory processes such as pyelonephritis caused by Escherichia coli pneumonia with pleural effusion caused by Streptococcus pneumoniae or sepsis
Detailed Description:
Many studies demonstrated immune differences between men and women suffering from acute and chronic inflammatory processes In cases of acute inflammatory diseases such as sepsis females have better prognosis comparing to males 124-28
On the contrary worse prognosis for women is observed in chronic inflammatory diseases such as asthma or cystic fibrosis 8-10121329
Sex-depended inflammatory response was attributed to the influence of sex hormones on the immune system 215-18 However recent studies revealed differences in the clinical outcome but also in inflammatory markers between boys and girls suffering from acute and chronic inflammatory diseases 19-23 Sex hormone levels in prepubertal children are particularly low and insufficient to explain the gender differences observed in inflammatory conditions from neonates to the elderly suggesting the contribution of another mechanism such as the influence of genes situated on the sex chromosomes and involved in the inflammatory response
The aim of this work is to identify the potential X-linked mechanisms responsible for some of the differences between boys and girls in the inflammatory response making the girls more at risk of developing complications in chronic inflammatory diseases and the boys more at risk of lethal complications in severe acute inflammatory diseases like sepsis Several genes coding for innate immunity components are linked to the X chromosome such as diapedesis molecule CD99 or TLR pathway proteins genes 30-33 X chromosome is also highly enriched in genes encoding micro RNAs miRNAs involved in the post-transcriptional regulation of gene expression which play a critical role in immune inflammatory response 34-36
Thus in order to discriminate more precisely the role of the X chromosome relatively to the sex steroids in the sex-specific inflammatory response some innate immune functions related to X-linked genes will be evaluated in whole blood from prepubertal children of both sexes suffering from acute inflammatory processes such as pyelonephritis caused by Escherichia coli pneumonia with pleural effusion caused by Streptococcus pneumoniae or sepsis We will also study the correlations between inflammatory and clinical markers of the disease activity to identify prognosis indicators depending on the sex Additionally to delineate microbiome contribution we will study the gut microbiota in stool samples obtained from the recruited patients
On the contrary worse prognosis for women is observed in chronic inflammatory diseases such as asthma or cystic fibrosis 8-10121329
Sex-depended inflammatory response was attributed to the influence of sex hormones on the immune system 215-18 However recent studies revealed differences in the clinical outcome but also in inflammatory markers between boys and girls suffering from acute and chronic inflammatory diseases 19-23 Sex hormone levels in prepubertal children are particularly low and insufficient to explain the gender differences observed in inflammatory conditions from neonates to the elderly suggesting the contribution of another mechanism such as the influence of genes situated on the sex chromosomes and involved in the inflammatory response
The aim of this work is to identify the potential X-linked mechanisms responsible for some of the differences between boys and girls in the inflammatory response making the girls more at risk of developing complications in chronic inflammatory diseases and the boys more at risk of lethal complications in severe acute inflammatory diseases like sepsis Several genes coding for innate immunity components are linked to the X chromosome such as diapedesis molecule CD99 or TLR pathway proteins genes 30-33 X chromosome is also highly enriched in genes encoding micro RNAs miRNAs involved in the post-transcriptional regulation of gene expression which play a critical role in immune inflammatory response 34-36
Thus in order to discriminate more precisely the role of the X chromosome relatively to the sex steroids in the sex-specific inflammatory response some innate immune functions related to X-linked genes will be evaluated in whole blood from prepubertal children of both sexes suffering from acute inflammatory processes such as pyelonephritis caused by Escherichia coli pneumonia with pleural effusion caused by Streptococcus pneumoniae or sepsis We will also study the correlations between inflammatory and clinical markers of the disease activity to identify prognosis indicators depending on the sex Additionally to delineate microbiome contribution we will study the gut microbiota in stool samples obtained from the recruited patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None