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

August 31, 2023 updated by: East Suffolk and North Essex NHS Foundation Trust

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children with Autism
Neurotypical siblings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: 0 weeks
Gut microbiota composition of faeces of children with ASD
0 weeks
Gut microbiota
Time Frame: 6 weeks
Gut microbiota composition of faeces of children with ASD
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 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)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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