Dietetic Pattern in Children With Autism Spectrum Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Gut Microbiota, Nutrition and Adverse Reactions to Food in Children With Autism Spectrum Disorders

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Children with autism spectrum disorders


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with autism spectrum disorders<br>Children affected by autism spectrum disorders | Behavioral: Children with autism spectrum disorders<br>* Subjects affected by autism spectrum disorders<br>|
| Healthy controls<br>Healthy children | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse food reactions | The evaluation of the occurrence of food reaction is study population | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating habits | The evaluation of eating habits with the 3-day food diary | at the entrollment | 
| Nutritional status | The evaluation of nutritional status with the collection of auxological data | at the entrollment | 
| Composition of gut microbiota | The evaluation of intestinal microbiota with the shotgun analysis | at the entrollment | 
| Function of gut microbiota | The evaluation of short chain fatty acids with the gascromatography | at enrollment |