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OpenTrials
Completed

NCT Number: NCT05794620

Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

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.

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Key information

Conditions

Autism Spectrum Disorder Autism Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

East Suffolk and North Essex Nhs Foundation Trust

Colchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool sample

Other

Stool sample

Primary outcomes

  1. Gut microbiota

    Time frame: 0 weeks

    Gut microbiota composition of faeces of children with ASD

Other outcomes

  1. Gut microbiota

    Time frame: 6 weeks

    Gut microbiota composition of faeces of children with ASD

Sponsors and collaborators

Lead sponsor

East Suffolk and North Essex NHS Foundation Trust

Other

Collaborators

  • Quadram Institute Bioscience

Registry information

Official study title

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

Acronym: FAMILY

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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