Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

NCT ID: NCT05794620

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-20

Study Completion Date

2024-04-12

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder Autism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with Autism

A child with a diagnosis of Autism

Stool sample

Intervention Type OTHER

Stool sample

Neurotypical siblings

A full sibling of the child with Autism

Stool sample

Intervention Type OTHER

Stool sample

Interventions

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Stool sample

Stool sample

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quadram Institute Bioscience

OTHER

Sponsor Role collaborator

East Suffolk and North Essex NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Marlow

Role: PRINCIPAL_INVESTIGATOR

East Suffolk and North Essex NHS Foundation Trust

Locations

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East Suffolk and North Essex Nhs Foundation Trust

Colchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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22/045

Identifier Type: -

Identifier Source: org_study_id

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