Actively Recruiting

Age: 1Year - 17Years
All Genders
NCT05830591

Gut-oral Axis Microbiome in Autism Spectrum Disorders

Led by IRCCS Burlo Garofolo · Updated on 2024-06-14

86

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Gut-oral Axis Microbiome in Autism Spectrum Disorders

Who Can Participate

Age: 1Year - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Caucasian children aged between 1 and 17 years
  • Diagnosed with Autism Spectrum Disorder (ASD) or newly diagnosed with ASD (case group)
  • Caucasian children aged between 1 and 17 years who are healthy with no ASD or neurological disorders (control group)
Not Eligible

You will not qualify if you...

  • Antibiotic use in the month before sample collection
  • Probiotic use in the month before sample collection
  • Presence of other neurological diseases
  • Presence of chronic inflammatory diseases
  • Use of constipation drugs during the three days before sample collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Trieste, Italy, 34137

Actively Recruiting

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Research Team

M

Manola Comar, BSc

CONTACT

M

Manola Comar, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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