Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

NCT05794620 | Completed DMC

• 1 other identifier: 22/045
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  Gut microbiota composition of faeces of children with ASD

  0 weeks

Other Outcomes (1)

• Gut microbiota

  6 weeks

Study Arms (2)

Children with Autism

A child with a diagnosis of Autism

Other: Stool sample

Neurotypical siblings

A full sibling of the child with Autism

Other: Stool sample

Interventions

Stool sample OTHER

Stool sample

Children with Autism; Neurotypical siblings

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with ASD

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Quadram Institute Bioscience: collaborator
• East Suffolk and North Essex NHS Foundation Trust: lead

Study Sites (1)

East Suffolk and North Essex Nhs Foundation Trust

Colchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal samples

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ben Marlow

  East Suffolk and North Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: December 20, 2022
• Primary Completion: April 8, 2024
• Study Completion: April 12, 2024
• Last Updated: February 9, 2026

Record last verified: 2024-09

Locations

GB (1)