Autism Spectrum DisorderFAMILYNCT05794620
Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings
An observational study of Autism Spectrum Disorder and Autism, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Stool sample
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Dec 2022to 12 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with ASD
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Suffolk and North Essex Nhs Foundation Trust
Colchester
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Stool sample
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleOther
Stool sample
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism | A child with a diagnosis of Autism Receives: Other: Stool sample | |
| Neurotypical siblings | A full sibling of the child with Autism Receives: Other: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Gut microbiota composition of faeces of children with ASD
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start20 Dec 2022
- Primary completion8 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Suffolk and North Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Responsible party
- Sponsor
- Investigators
- Ben Marlow, Principal investigator, East Suffolk and North Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794620
- Sponsor's protocol ID
- 22/045
- Acronym
- FAMILY
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings: FAMILY
- ClinicalTrials.gov ID
- NCT05794620
- Acronym / sponsor ID
- FAMILY / 22/045
- Conditions
- Autism Spectrum Disorder, Autism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- East Suffolk and North Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Autism | – | Other: Stool sampleA child with a diagnosis of Autism |
| Neurotypical siblings | – | Other: Stool sampleA full sibling of the child with Autism |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with ASD
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool sampleStool sample | Other | Children with Autism, Neurotypical siblings |
Primary outcome
Gut microbiota
Time frame: 0 weeks
Gut microbiota composition of faeces of children with ASD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Marlow principal investigator
East Suffolk and North Essex NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autism, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: 0 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.