Viewing Study NCT04890717



Ignite Creation Date: 2024-05-06 @ 4:09 PM
Last Modification Date: 2024-10-26 @ 2:05 PM
Study NCT ID: NCT04890717
Status: RECRUITING
Last Update Posted: 2023-02-08
First Post: 2021-05-09

Brief Title: Biomarkers for Autism and ADHD in Children
Sponsor: Chinese University of Hong Kong
Organization: Chinese University of Hong Kong

Study Overview

Official Title: Microbial Stool Biomarkers for Prediction of Autism and ADHD in Children
Status: RECRUITING
Status Verified Date: 2023-02
Last Known Status: None
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: None
Brief Summary: Autism ASD is one of the frequent neurodevelopmental disorders that children would occur Many studies have shown that individuals with Autism are more common to experience significant gastrointestinal problems than other individuals Symptoms include constipation diarrhea abdominal pain and gastric reflux A recent study with 50 children with ASD 50 children with other developmental disabilities and 50 healthy control children it found that 70 of ASD children had presented with GI symptoms compared with 42 of developmental disabilities children and 28 of developing children it is believed that ASD children will have a distinctive microbial pattern in the stool

Attention-deficithyperactivity disorder ADHD is another neurodevelopmental and neurobehavioral disorder A study found that ADHD individuals experience significantly higher rate of stomach pain and bowel problems than other control individuals It is suggested that the microbiota in the stool of ADHD children might be different Genetic study also found that if a child has a sibling with ADHD the risk of developing ADHD is three to four times higher than that of children with siblings without ADHD
Detailed Description: Autism Spectrum Disorder ASD was first developed by Kanner in 1943 In Hong Kong a study showed that as many as 49 out of 10000 children were diagnosed in Autism ASD is one of the frequent neurodevelopmental disorders that children would occur Many studies have shown that individuals with Autism are more common to experience significant gastrointestinal problems than other individuals Symptoms include constipation diarrhoea abdominal pain and gastric reflux In a study with 160 children with ASD 59 had GI symptoms including diarrhoea unformed stool constipation bloating and gastroesophageal reflux GERD A study compared 51 ASD children and 40 healthy control children found that 63 of ASD children had moderate or severe diarrhoea and constipation symptoms In contrast only 2 of control children had such experience Similarly a study of 150 children with 50 children with ASD 50 children with other developmental disabilities and 50 healthy control children it found that 70 of ASD children had presented with GI symptoms compared with 42 of developmental disabilities children and 28 of developing children Other study stated that such untreated GI symptoms might worsen the behavioural issue of ASD children As there is a strong relationship between ASD children and GI symptoms it is believed that ASD children will have a distinctive microbial pattern in the stool

Attention-deficithyperactivity disorder ADHD is another neurodevelopmental and neurobehavioral disorder In Hong Kong there were 89 of ADHD children among Primary one Chinese schoolboys A large study N6483 found that ADHD individuals experience a significantly higher rate of stomach pain and bowel problems than other control individuals McKeown did another study also reported that ADHD children were more likely to experience constipation and stool incontinence than normal healthy children In one study that compared the Gastrointestinal Severity Index scoring between children with ADHD and healthy subjects children with ADHD had significantly higher mean and scored higher in constipation diarrhoea and flatulence variables As the findings of ADHD individuals and gastrointestinal symptoms are closely associated the microbiota in the stool might be different from normal children without ADHD

Accumulating evidence implicated gut microbiota play a role in autism spectrum disorder ASD A huge community of microorganisms in the gastrointestinal GI tract impacts the development and function of the immune metabolic and nervous systems via the gut-brain axis Majority of studies shown the diversity of gut microbiota changed in children with ASD compared with that of typically developing TD children suggesting that the overall microbiota composition altered in ASD Differences were observed between ASD and TD when comparing the abundance of bacteria in phyla and species level Potential faecal bacteria biomarkers in the stool of children with ASD will be a useful non-invasive tool for early detection that will benefit more children with suspected conditions

The microbiota was involved in many aspects of behaviour was confirmed in animal studies and human trial but it remains unclear whether gut microbiota recover in children with ASD after the intervention Genetic research has revealed that if a child has a sibling with ADHD the risk of developing ADHD is three to four times higher than that of children with siblings without ADHD

Besides previous studies showed that maternal unhealthy diet tobacco use and the harmful use of alcohol during pregnancy induce a shift in microbial ecology that negatively impacts offspring social behavior and has a fundamental role in the etiopathogenesis of ASD and ADHD In some cases children who have experienced stress emotional abuse and violence are more prone to ADHD behaviour

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