Gut-oral Axis Microbiome in Autism Spectrum Disorders

NCT05830591 | Recruiting

• 1 other identifier: RC 20/21
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Autism Spectrum Disorder (ASD) is a neurodevelopment disorder characterized by impairment in social interaction, communication, and behavior, as well as sensory challenges. In addition, secondary symptoms can appear, such as gastrointestinal disorders. Gut microbiota has an important role in the harvest of nutrients and energy from our diet. It influences a wide range of metabolic, developmental, and physiological processes such as the maintenance of the gut epithelial layer, immune system development, protection against pathogens, detoxification and xenobiotics degradation. The ecosystem of a healthy human gastrointestinal (GI) tract is mainly populated by Firmicutes and Bacteroidetes phyla, to a lesser extent by Actinobacteria and Proteobacteria, in this case the microbiota is in an eubiosis condition. Whether a disturbance of the microbial ecosystem occurs, gut microbiota is in a dysbiosis condition and it could lead different metabolic disorders. The two-way communication between gut microbiota and central nervous system (CNS) affects stress response, pain perception, neurochemistry and several disorders. The gut microbiota in ASD patients revealed some peculiarities such as the high percentage of Propionibacter and Clostridium, well known for their production of pro inflammatory metabolites, or an increment of Sutterella spp. and Ruminococcus torques, which are negatively associated with the health of the gut. Recent studies suggest that also the oral microbiota may be involved in ASD symptoms assuming the existence of a "microbiota-oral-brain axis". ASD patients are often suffering of several oral cavity disorders like caries, gingivitis and periodontitis, probably due to the poor oral hygiene. These disorders are linked to a dysbiosis of the oral microbiota: the characterization of the ASD subjects oral microbiota showed a lower biodiversity of bacteria species and different levels of specific bacteria, comparing to the controls. Several studies suggest that some bacteria species invade the blood-brain barriers as well as their metabolites, triggering inflammatory response and an alteration of the metabolic activity in the CNS. It has been demonstrated that ASD patients have a high level of pro-inflammatory cytokines and chemokines in the cerebrospinal fluid and an upregulation of the microglia. The oral microbiota could also affect the lower GI tract and have a significant role within the ASD-associated GI disorders and CNS inflammation

Conditions

Autism Spectrum Disorder; Microbiota

Keywords

Autism Spectrum Disorder; Microbiota; Inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

• To compare oral and GI microbiota

  Oral and GI bacterial species will be evaluated in oral and fecal samples collected and compared through bioinformatic and statistical analysis among case and control groups to isolate the discriminant ones. The technical activity is focused on samples DNA extraction and sequencing and on a culturomic approach.

  At baseline

Secondary Outcomes (4)

• To evaluate the association between the key bacteria species found in ASD microbiota and soluble concentration of salivary cytokines

  At baseline

• To evaluate the association between the key bacteria species found in ASD microbiota and soluble concentration of salivary chemokines

  At baseline

• To evaluate the association between the microbiota structure and the severity of the ASD symptoms

  At baseline

• To evaluate the association between the microbiota structure and eating habits of ASD children

  At baseline

Study Arms (3)

Children with autism disorders 1-5 years

Children coming to the Division of Child Neurology and Psychiatry for the first clinical evaluation (1 year to 5 years old)

Other: Characterization of the microbiome in oral and fecal samples

Children with autism disorders 6-17 years

Children with confirmed ASD diagnosis (6 years to 17 years old) coming to the Odonto-Stomatology Department for the periodical dental hygiene session

Other: Characterization of the microbiome in oral and fecal samples

Children control group

Children with matched demographic characteristics accessing our Institute for different purposes

Other: Characterization of the microbiome in oral and fecal samples

Interventions

Characterization of the microbiome in oral and fecal samples OTHER

The oral and fecal samples are collected during the periodical dental hygiene session at the odonto-stomatology unit and during day hospital for younger children admitted for the first clinical evaluation at Division of Child Neurology and Psychiatry. Procedures will follow standardized protocols.

Children control group; Children with autism disorders 1-5 years; Children with autism disorders 6-17 years

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric subjects: * children coming to the Division of Child Neurology and Psychiatry for the first clinical evaluation (1 year to 5 years old) * children with confirmed ASD diagnosis (6 years to 17 years old) coming to the Odonto-Stomatology Department for the periodical dental hygiene session. * children control group with matched demographic characteristics accessing our Institute for different purposes

You may qualify if:

• Case group
• Caucasian
• Diagnosed with ASD or with a newly formulated diagnosis of ASD
• Aged between 1 and 17 years
• Control group
• Caucasian
• Healthy at the time of sampling
• No ASD or other neurological disorders
• Aged between 1 and 17 years

You may not qualify if:

• Antibiotic use in the month before sample collection
• Probiotic use in the month before sample collection
• Other neurological diseases
• Chronic inflammatory diseases
• The use of constipation drugs during the three days before sample collection

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oral swabs and fecal samples

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Manola Comar, BSc

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  STUDY DIRECTOR

Central Study Contacts

Manola Comar, BSc

CONTACT

+39.040.3785.527; manola.comar@burlo.trieste.it

Manola Comar, BSc

CONTACT

+390403785527; manola.comar@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 26, 2023
• Study Start: May 20, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

IT (1)