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Dietetic Pattern in Children With Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04719923
Recruitment Status : Completed
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief 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. 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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Behavioral: Children with autism spectrum disorders

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gut Microbiota, Nutrition and Adverse Reactions to Food in Children With Autism Spectrum Disorders
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Subjects with autism spectrum disorders
Children affected by autism spectrum disorders
Behavioral: Children with autism spectrum disorders
Subjects affected by autism spectrum disorders

Healthy controls
Healthy children

Primary Outcome Measures :
  1. Adverse food reactions [ Time Frame: at enrollment ]
    The evaluation of the occurrence of food reaction is study population

Secondary Outcome Measures :
  1. Eating habits [ Time Frame: at the entrollment ]
    The evaluation of eating habits with the 3-day food diary

  2. Nutritional status [ Time Frame: at the entrollment ]
    The evaluation of nutritional status with the collection of auxological data

  3. Composition of gut microbiota [ Time Frame: at the entrollment ]
    The evaluation of intestinal microbiota with the shotgun analysis

  4. Function of gut microbiota [ Time Frame: at enrollment ]
    The evaluation of short chain fatty acids with the gascromatography

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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)

Inclusion Criteria:

  • subjects with diagnosis Autism Spectrum Disorde

Exclusion Criteria:

  • Concomitant presence of:
  • epilepsy
  • neurological syndromes,
  • chronic diseases
  • immunodeficiencies,
  • diabetes,
  • congenital heart disease,
  • autoimmune diseases,
  • inborn errors of metabolism,
  • tuberculosis,
  • cystic fibrosis,
  • chronic tract diseases respiratory,
  • inflammatory bowel diseases,
  • celiac disease,
  • eosinophilic diseases of the gastrointestinal tract,
  • functional gastrointestinal disorders,
  • obesity,
  • tumors,
  • malnutrition.

    •Major malformations

  • previous surgeries of the gastrointestinal / urinary / respiratory tract •Use of antibiotics and / or pre / pro / synbiotics during the 12 weeks prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719923

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University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
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Responsible Party: Roberto Berni Canani, Associate Professor - Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies, Federico II University
ClinicalTrials.gov Identifier: NCT04719923    
Other Study ID Numbers: 312/17
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders