Autism Spectrum DisorderMTANCT03751930
Intestinal Microbiota, Tryptophan and Autism
An observational study of Autism Spectrum Disorder, run by University Hospital, Tours at 2 sites in France.
Trial summary
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Samples
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jan 2019to 28 Oct 2021
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 3-12 year old children with and without Autism Spectrum Disorders
Who may be able to join
- 3-12 year old child
- Diagnosis of Autism Spectrum Disorders according to the DSM-5 (2013), invasive developmental disorder according to the ICD-10 (1993) or Autism Spectrum Disorders according to ICD-11 (2018)
- Affiliate or beneficiary of a social security scheme
- Consent signed by at least one of the parents
- 3-12 year old child
- Affiliate or beneficiary of a social security scheme
- Consent signed by both parents
Who cannot join
- Chronic inflammatory pathology
- Probiotic intake
- Taking medication (except melatonin) within 6 days before inclusion and until biological samples are collected
- Chronic inflammatory pathology
- Digestive pathology
- Probiotic intake
- Taking medication within 6 days before inclusion and until biological samples are collected
- Personal and / or family history of neurological disease, epilepsy, psychiatric disorder, neurodevelopmental disorder, language disorder, overdrive, intellectual disability
Trial locations and contacts
2 sites in 1 country.
France2 sites
Child psychiatry department, University Hospital, Tours
Tours, 37044
Clinical investigation center, University Hospital, Tours
Tours, 37044
About this study
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.
The overall goal of this project is the identification of metabolic biomarkers based on clinical profile. The best characterization of physiopathological pathways will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.
The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.
Read the detailed description
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. In France, Autism Spectrum Disorderaffects about 1 in 100 people according to international criteria and is diagnosed in early childhood. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.
The overall goal of this project is the identification of metabolic biomarkers based on clinical profile (based on behavioral and cognitive markers). The best characterization of physiopathological pathways (from the molecular scale to the phenotypic scale) will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.
The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Samples
- Keywords
- Autism Spectrum Disorder, Tryptophan metabolism, Gut microbiota
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Urinary and faecal samples
| Study group | Role | What they receive |
|---|---|---|
| Patients with Autism Spectre Disorders | Taken biological samples on patients with Autism Spectre Disorders Receives: Other: Samples | |
| Healthy volunteers | Taken biological samples on patients healthy volunteers Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary concentrations of tryptophan metabolites
Quantification by High-Performance Liquid Chromatography and Mass Spectrometry
Measured: At baseline
Faecal concentrations of tryptophan metabolites
Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry
Measured: At baseline
Secondary outcomes (2)
Characterization of gut microbiota
Characterization by 16S ribosomal RNA sequencing
Measured: At baseline
Correlation of metabolic profiles of tryptophan and microbiotic profiles
Study of correlations from the outcomes measures 1, 2 and 3
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start2 Jan 2019
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick EMOND, MD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751930
- Sponsor's protocol ID
- DR180136
- Other IDs
- 2018-A01086-49
- Acronym
- MTA
- Status last verified
- May 2022
- First submitted
- 21 Nov 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota, Tryptophan and Autism
- ClinicalTrials.gov ID
- NCT03751930
- Acronym / sponsor ID
- MTA / DR180136
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Tryptophan metabolism, Gut microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 23 Nov 2018 (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.
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.
The overall goal of this project is the identification of metabolic biomarkers based on clinical profile. The best characterization of physiopathological pathways will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.
The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.
Detailed description
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. In France, Autism Spectrum Disorderaffects about 1 in 100 people according to international criteria and is diagnosed in early childhood. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.
The overall goal of this project is the identification of metabolic biomarkers based on clinical profile (based on behavioral and cognitive markers). The best characterization of physiopathological pathways (from the molecular scale to the phenotypic scale) will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.
The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Autism Spectre Disorders | – | Other: SamplesTaken biological samples on patients with Autism Spectre Disorders |
| Healthy volunteers | – | Other: SamplesTaken biological samples on patients healthy volunteers |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 3-12 year old children with and without Autism Spectrum Disorders
Key inclusion criteria (7 listed)
- 3-12 year old child
- Diagnosis of Autism Spectrum Disorders according to the DSM-5 (2013), invasive developmental disorder according to the ICD-10 (1993) or Autism Spectrum Disorders according to ICD-11 (2018)
- Affiliate or beneficiary of a social security scheme
- Consent signed by at least one of the parents
- 3-12 year old child
Key exclusion criteria (8 listed)
- Chronic inflammatory pathology
- Probiotic intake
- Taking medication (except melatonin) within 6 days before inclusion and until biological samples are collected
- Chronic inflammatory pathology
- Digestive pathology
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 |
|---|---|---|
| SamplesUrinary and faecal samples | Other | Healthy volunteers, Patients with Autism Spectre Disorders |
Primary outcome
Urinary concentrations of tryptophan metabolites
Time frame: At baseline
Quantification by High-Performance Liquid Chromatography and Mass Spectrometry
Faecal concentrations of tryptophan metabolites
Time frame: At baseline
Quantification by using High-Performance Liquid Chromatography and Mass Spectrometry
2 secondary outcomes
Characterization of gut microbiota
Time frame: At baseline
Correlation of metabolic profiles of tryptophan and microbiotic profiles
Time frame: At baseline
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 25 May 2022.
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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.
Patrick EMOND, MD study director
University Hospital, Tours
2 sites 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, run by University Hospital, Tours at 2 sites in France.
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 7 inclusion and 8 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Urinary concentrations of tryptophan metabolites (time frame: At baseline). The study lists 2 primary outcomes in all. 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 25 May 2022.