- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04719923
Dietetic Pattern in Children With Autism Spectrum Disorders
January 18, 2021 updated by: Roberto Berni Canani, Federico II University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Naples, Italy, 80131
- University of Naples Federico II
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 7 years (CHILD)
Accepts Healthy Volunteers
N/A
Genders 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)
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects with autism spectrum disorders
Children affected by autism spectrum disorders
|
Subjects affected by autism spectrum disorders
|
Healthy controls
Healthy children
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse food reactions
Time Frame: at enrollment
|
The evaluation of the occurrence of food reaction is study population
|
at enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating habits
Time Frame: at the entrollment
|
The evaluation of eating habits with the 3-day food diary
|
at the entrollment
|
Nutritional status
Time Frame: at the entrollment
|
The evaluation of nutritional status with the collection of auxological data
|
at the entrollment
|
Composition of gut microbiota
Time Frame: at the entrollment
|
The evaluation of intestinal microbiota with the shotgun analysis
|
at the entrollment
|
Function of gut microbiota
Time Frame: at enrollment
|
The evaluation of short chain fatty acids with the gascromatography
|
at enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
October 1, 2020
Study Completion (ACTUAL)
October 1, 2020
Study Registration Dates
First Submitted
January 18, 2021
First Submitted That Met QC Criteria
January 18, 2021
First Posted (ACTUAL)
January 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 18, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 312/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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