Autism Spectrum DisorderNCT04719923
Dietetic Pattern in Children With Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by Federico II University at 1 site in Italy.
Trial summary
To date, it is well documented that the gut microbiota (GM) influences numerous physiological processes in the healthy "host". The alteration of the composition and function of the intestinal microbiota, commonly referred to as "dysbiosis", is associated with many pathological conditions. Read more about this study
- Who is it for?
- Ages 18 months to 7 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Children with autism spectrum disorders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 1 Oct 2020
- 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 18 months to 7 years
- All sexes
- Child
Study population: 200 subjects of both sexes diagnosed with Autism Spectrum Disorder (ASD),aged between 18 months and 7 years, consecutively observed in the care facility of the Department of Translational Medical Sciences, University of Naples "Federico II" or healthy controls (100/group)
Who may be able to join
- subjects with diagnosis Autism Spectrum Disorder or healthy controls
Who cannot join
- Concomitant presence of:
- epilepsy
- neurological syndromes,
- immunodeficiencies,
- type 1 diabetes
- endocrine diseases,
Show all 16Show fewer
- congenital heart disease,
- inborn errors of metabolism,
- tuberculosis,
- cystic fibrosis,
- chronic tract diseases respiratory,
- malignancy,
- •Major malformations
- previous surgeries of the gastrointestinal / urinary / respiratory tract
- Use of antibiotics or anti-mycotic and / or pre / pro / synbiotics during the 12 weeks prior to enrollment.
- investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiota, Nutrition and Adverse Reactions to Food in Children With Autism Spectrum Disorders
To date, it is well documented that the gut microbiota (GM) influences numerous physiological processes in the healthy "host". The alteration of the composition and function of the intestinal microbiota, commonly referred to as "dysbiosis", is associated with many pathological conditions. The high co-morbidity between inflammatory bowel diseases and psychiatric symptoms such as anxiety and stress and the frequent presence of gastrointestinal dysfunctions in autistic patients have highlighted a possible implication of GM in psychiatric disorders. The ability of GM to communicate with the central nervous system and the possible influence on behavior led to the discovery of the existence of a microbiota-gut-brain axis. Clinical and experimental data suggest a possible role of modifications in the composition and function of the intestinal microbiota (impaired production of short-chain fatty acids, SCFAs) in major psychiatric disorders such as autism spectrum disorders (ASD). ASD is a severe neurological condition characterized by severe stereotypical behaviors and deficits in linguistic and social interaction. The prevalence of ASD in children is continuously increasing in Western countries. The pathogenesis of ASD is still poorly defined. The clinical manifestations of ASD are the result of complex interactions between genetic, epigenetic, environmental and microbiological factors. The improvement in gastrointestinal symptoms of autistic patients after short-term oral treatment with antibiotics and probiotics clearly indicated a role of the metabolites of MI in ASD. In particular, an alteration in the phyla of Bacteroidetes and Firmicutes in fecal samples from autistic children has been described with conflicting results. Williams and colleagues (2011) evaluated a significant increase in the Firmicutes / Bacteroidetes ratio in intestinal biopsies of autistic children with gastrointestinal disorders. It has also been shown in animal models of ASD that dysbiosis is positively associated with an increase in butyrate levels and inversely associated with the "score" of the severity of ASD symptoms. Alterations in nutritional status, eating habits and adverse reactions to food appear to be more frequent in children with ASD. Several studies support the hypothesis that children with ASD have a greater refusal of food, requiring specific food presentations or eating a reduced variety of foods compared to children without ASD. These conditions are associated with dysbiosis. Preliminary data suggest that particular elimination diets and / or modifications of the intestinal microbiota can determine a positive effect on the symptoms of ASD. A better knowledge of the composition and functions of the intestinal microbiota also in relation to eating habits and the presence of adverse reactions to food in the child with ASD could facilitate new effective strategies for the prevention and treatment of these conditions.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Children with autism spectrum disorders
- 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.
Children with autism spectrum disordersBehavioural
Subjects affected by autism spectrum disorders
| Study group | Role | What they receive |
|---|---|---|
| Subjects with autism spectrum disorders | Children affected by autism spectrum disorders Receives: Behavioral: Children with autism spectrum disorders | |
| Healthy controls | Healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse food reactions
The evaluation of the occurrence of food reaction is study population
Measured: at enrollment
Secondary outcomes (4)
Eating habits
The evaluation of eating habits with the 3-day food diary
Measured: at the entrollment
Nutritional status
The evaluation of nutritional status with the collection of auxological data
Measured: at the entrollment
Composition of gut microbiota
The evaluation of intestinal microbiota with the shotgun analysis
Measured: at the entrollment
Function of gut microbiota
The evaluation of short chain fatty acids with the gascromatography
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2017
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719923
- Sponsor's protocol ID
- 312/17
- Status last verified
- May 2024
- First submitted
- 18 Jan 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coppola S, Nocerino R, Oglio F, Golia P, Falco MC, Riccio MP, Carucci L, Rea T, Simeone S, Garotti R, Marani N, Bravaccio C, Canani RB. Adverse food reactions and alterations in nutritional status in children with autism spectrum disorders: results of the NAFRA project. Ital J Pediatr. 2024 Nov 4;50(1):228. doi: 10.1186/s13052-024-01794-8.
PubMed 39497088
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota, Nutrition and Adverse Reactions to Food in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT04719923
- Acronym / sponsor ID
- 312/17
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 22 Jan 2021 (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.
To date, it is well documented that the gut microbiota (GM) influences numerous physiological processes in the healthy "host". The alteration of the composition and function of the intestinal microbiota, commonly referred to as "dysbiosis", is associated with many pathological conditions. The high co-morbidity between inflammatory bowel diseases and psychiatric symptoms such as anxiety and stress and the frequent presence of gastrointestinal dysfunctions in autistic patients have highlighted a possible implication of GM in psychiatric disorders. The ability of GM to communicate with the central nervous system and the possible influence on behavior led to the discovery of the existence of a microbiota-gut-brain axis. Clinical and experimental data suggest a possible role of modifications in the composition and function of the intestinal microbiota (impaired production of short-chain fatty acids, SCFAs) in major psychiatric disorders such as autism spectrum disorders (ASD). ASD is a severe neurological condition characterized by severe stereotypical behaviors and deficits in linguistic and social interaction. The prevalence of ASD in children is continuously increasing in Western countries. The pathogenesis of ASD is still poorly defined. The clinical manifestations of ASD are the result of complex interactions between genetic, epigenetic, environmental and microbiological factors. The improvement in gastrointestinal symptoms of autistic patients after short-term oral treatment with antibiotics and probiotics clearly indicated a role of the metabolites of MI in ASD. In particular, an alteration in the phyla of Bacteroidetes and Firmicutes in fecal samples from autistic children has been described with conflicting results. Williams and colleagues (2011) evaluated a significant increase in the Firmicutes / Bacteroidetes ratio in intestinal biopsies of autistic children with gastrointestinal disorders. It has also been shown in animal models of ASD that dysbiosis is positively associated with an increase in butyrate levels and inversely associated with the "score" of the severity of ASD symptoms. Alterations in nutritional status, eating habits and adverse reactions to food appear to be more frequent in children with ASD. Several studies support the hypothesis that children with ASD have a greater refusal of food, requiring specific food presentations or eating a reduced variety of foods compared to children without ASD. These conditions are associated with dysbiosis. Preliminary data suggest that particular elimination diets and / or modifications of the intestinal microbiota can determine a positive effect on the symptoms of ASD. A better knowledge of the composition and functions of the intestinal microbiota also in relation to eating habits and the presence of adverse reactions to food in the child with ASD could facilitate new effective strategies for the prevention and treatment of these conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with autism spectrum disorders | – | Behavioral: Children with autism spectrum disordersChildren affected by autism spectrum disorders |
| Healthy controls | – | –Healthy children |
Who may qualify
- Ages
- 18 months to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- 200 subjects of both sexes diagnosed with Autism Spectrum Disorder (ASD),aged between 18 months and 7 years, consecutively observed in the care facility of the Department of Translational Medical Sciences, University of Naples "Federico II" or healthy controls (100/group)
Key inclusion criteria (1 listed)
- subjects with diagnosis Autism Spectrum Disorder or healthy controls
Key exclusion criteria (16 listed)
- Concomitant presence of:
- epilepsy
- neurological syndromes,
- immunodeficiencies,
- type 1 diabetes
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 |
|---|---|---|
| Children with autism spectrum disordersSubjects affected by autism spectrum disorders | Behavioural | Subjects with autism spectrum disorders |
Primary outcome
Adverse food reactions
Time frame: at enrollment
The evaluation of the occurrence of food reaction is study population
4 secondary outcomes
Eating habits
Time frame: at the entrollment
Nutritional status
Time frame: at the entrollment
Composition of gut microbiota
Time frame: at the entrollment
Function of gut microbiota
Time frame: at enrollment
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 May 2024.
- Derived from this study: PubMed 39497088Coppola S, Nocerino R, Oglio F, Golia P, Falco MC, Riccio MP, Carucci L, Rea T, Simeone S, Garotti R, Marani N, Bravaccio C, Canani RB. Adverse food reactions and alterations in nutritional status in children with autism spectrum disorders: results of the NAFRA project. Ital J Pediatr. 2024 Nov 4;50(1):228. doi: 10.1186/s13052-024-01794-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Federico II University at 1 site in Italy.
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 1 inclusion and 16 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 May 2024. 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 Italy. 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?
Adverse food reactions (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719923, which also lists 1 linked publication.
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 May 2024.