Exploring the gut-oral microbiome in autism spectrum disorders
The Role of Gut-oral Axis Microbiome in Autism Spectrum Disorders
This study looks at the bacteria in the mouths and guts of children with autism to see how it might be different from those without autism and how it could affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT05830591 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between gut microbiota and Autism Spectrum Disorder (ASD) by analyzing oral and fecal samples from participants. It aims to characterize the microbiome in both ASD patients and healthy controls, focusing on the differences in microbial composition and its potential impact on metabolic and physiological processes. The study will include Caucasian children aged 1 to 17 years, with specific inclusion and exclusion criteria to ensure the integrity of the data collected. By understanding the gut-oral axis in ASD, the research seeks to uncover potential links between microbiota and the disorder's symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are Caucasian children aged 1 to 17 years diagnosed with Autism Spectrum Disorder.
Not a fit: Patients with other neurological diseases or chronic inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of gut microbiota in ASD, potentially leading to new therapeutic strategies.
How similar studies have performed: While there have been studies exploring the gut microbiome in relation to various conditions, this specific focus on the gut-oral axis in ASD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Manola Comar, BSc
- Email: manola.comar@burlo.trieste.it
- Phone: +39.040.3785.527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.