Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings (FAMILY)

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Other: Stool sample

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Colchester, United Kingdom
    • East Suffolk and North Essex NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children with ASD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with Autism; A child with a diagnosis of Autism	Other: Stool sample; Stool sample
Neurotypical siblings; A full sibling of the child with Autism	Other: Stool sample; Stool sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Gut microbiota composition of faeces of children with ASD	0 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Gut microbiota composition of faeces of children with ASD	6 weeks

Collaborators and Investigators

• Sponsor: East Suffolk and North Essex NHS Foundation Trust
• Collaborators: Quadram Institute Bioscience
• Investigators: Principal Investigator: Ben Marlow, East Suffolk and North Essex NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 12, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 22/045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No