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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Italy1 site
  • University of Naples Federico II

    Naples, 80131

Other trials in Italy

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.

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 groups in NCT04719923
Study groupRoleWhat they receive
Subjects with autism spectrum disordersChildren affected by autism spectrum disorders
Receives: Behavioral: Children with autism spectrum disorders
Healthy controlsHealthy children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse food reactions

    The evaluation of the occurrence of food reaction is study population

    Measured: at enrollment

Secondary outcomes (4)
  1. Eating habits

    The evaluation of eating habits with the 3-day food diary

    Measured: at the entrollment

  2. Nutritional status

    The evaluation of nutritional status with the collection of auxological data

    Measured: at the entrollment

  3. Composition of gut microbiota

    The evaluation of intestinal microbiota with the shotgun analysis

    Measured: at the entrollment

  4. 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.

  1. First posted22 Jan 2021
  2. Study start1 Oct 2017
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2020

Resources

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)
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

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.

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Clinical Trial NCT04719923 | AzTrials