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Search / Trial NCT05830591

Gut-oral Axis Microbiome in Autism Spectrum Disorders

Launched by IRCCS BURLO GAROFOLO · Apr 13, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Autism Spectrum Disorder Microbiota Inflammatory Cytokines

ClinConnect Summary

This clinical trial is studying the relationship between gut and oral bacteria and Autism Spectrum Disorder (ASD). Researchers believe that the bacteria in our gut and mouth can affect not only our digestive health but also our brain and behavior. By comparing the gut and oral bacteria of children with ASD to those without the disorder, the study aims to understand how these bacteria might contribute to the symptoms of ASD and related gastrointestinal issues.

To participate, children aged 1 to 17 who are Caucasian and either have a diagnosis of ASD or are healthy without any neurological disorders can apply. However, those who have taken antibiotics or probiotics in the month before the study, or have other neurological or chronic inflammatory diseases, will not be eligible. Participants will provide samples of their gut and oral bacteria, which will help researchers learn more about how these microorganisms interact with health and behavior. This study is currently recruiting, and the findings could lead to new insights into managing ASD symptoms.

Gender

ALL

Eligibility criteria

  • INCLUSION CRITERIA
  • Case group
  • 1. Caucasian
  • 2. Diagnosed with ASD or with a newly formulated diagnosis of ASD
  • 3. Aged between 1 and 17 years
  • Control group
  • 1. Caucasian
  • 2. Healthy at the time of sampling
  • 3. No ASD or other neurological disorders
  • 4. Aged between 1 and 17 years
  • EXCLUSION CRITERIA
  • 1. Antibiotic use in the month before sample collection
  • 2. Probiotic use in the month before sample collection
  • 3. Other neurological diseases
  • 4. Chronic inflammatory diseases
  • 5. The use of constipation drugs during the three days before sample collection

About Irccs Burlo Garofolo

IRCCS Burlo Garofolo is a prestigious research institute located in Trieste, Italy, dedicated to advancing pediatric healthcare through innovative clinical research. As a recognized IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it focuses on a wide range of pediatric diseases, emphasizing the integration of clinical care and scientific research to improve patient outcomes. The institute collaborates with various national and international partners, fostering an environment of rigorous scientific inquiry and excellence in medical practice. Its commitment to ethical standards and patient safety ensures that all clinical trials conducted under its auspices contribute meaningful advancements in pediatric medicine.

Locations

Trieste, , Italy

Patients applied

0 patients applied

Trial Officials

Manola Comar, BSc

Study Director

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported