Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

Autism Spectrum Disorder Clinical Trial

— FAMILY  

Official title:

Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings: FAMILY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794620
• Other study ID #: 22/045
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2023
• Source: East Suffolk and North Essex NHS Foundation Trust
• Contact: Ben Marlow, MBBS
• Phone: 01473704787
• Email: Family[@]esneft.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Locations

Country	Name	City	State
United Kingdom	East Suffolk and North Essex Nhs Foundation Trust	Colchester

Sponsors (2)

Lead Sponsor	Collaborator
East Suffolk and North Essex NHS Foundation Trust	Quadram Institute Bioscience

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	Gut microbiota composition of faeces of children with ASD	0 weeks
Primary	Gut microbiota	Gut microbiota composition of faeces of children with ASD	6 weeks