Faecal Microbiota Analysis in Neurotypical and Autism Syn... | NCT05794620

Studies
Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

NCT05794620

Sponsor

East Suffolk and North Essex NHS Foundation Trust

Status

Completed

Last Update Posted

Feb 9, 2026Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Autism Spectrum Disorder
Autism

Interventions

Stool sample

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2022Actual

Primary Completion Date

Apr 8, 2024Actual

Completion Date

Apr 12, 2024Actual

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 9, 2026Actual

Name	Class
Quadram Institute Bioscience	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Stool sample	Other	Stool sample	Children with Autism Neurotypical siblings

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Children with ASD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben Marlow	East Suffolk and North Essex NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
East Suffolk and North Essex Nhs Foundation Trust		Colchester			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided