Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

Recruiting

• Conditions: Autism Spectrum Disorder; Autism
• Interventions: Other: Stool sample

• Registration Number: NCT05794620
• Lead Sponsor: East Suffolk and North Essex NHS Foundation Trust

Brief Summary

This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Children of both sexes who are diagnosed with ASD and under the care of ESNEFT who have a neurotypical sibling (either full or half sibling), who share their living environment. This is due to the study requiring stool samples that are from siblings, to control for genes and environment where possible.
• Aged 3 years to 10 years old (at time of consent)
• Parent/guardian able to consent to participate
• Parent/guardian able to complete required surveys (or with accommodated adjustments)

Exclusion Criteria

• Use of antibiotics in the previous 4 weeks
• Not under the care of ESNEFT
• Children <3 years old and >10 years old
• Children that don't have half or full siblings
• Parent/guardian unable to provide informed consent or complete surveys, despite reasonable adjustments being implemented

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with Autism	Stool sample	A child with a diagnosis of Autism
Neurotypical siblings	Stool sample	A full sibling of the child with Autism

Primary Outcome Measures

Name	Time	Method
Gut microbiota	0 weeks	Gut microbiota composition of faeces of children with ASD

Trial Locations

Locations (1)

East Suffolk and North Essex Nhs Foundation Trust; 🇬🇧 Colchester, United Kingdom