Exploring the link between gut health and brain barrier function in autism
Study of the Link Between Intestinal Dysbiosis and the Integrity of the Blood Brain Barrier in Autism
This study is trying to see if the health of the gut affects brain function in children with autism and how it might relate to their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04321915 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between intestinal microbiota composition and blood-brain barrier (BBB) integrity in children diagnosed with Autism Spectrum Disorder (ASD). It aims to understand how intestinal dysbiosis may contribute to neuroinflammation and potentially affect the severity of ASD symptoms. The study will analyze gut microbiota and neuroinflammation markers in a cohort of children aged 6 to 16 years who have been followed for at least three years. By examining these associations, the research seeks to uncover underlying pathophysiological pathways and the influence of nutritional status on ASD characteristics.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 16 years with a diagnosis of Autism Spectrum Disorder who have been part of the ELENA cohort.
Not a fit: Patients with syndromic autism, severe gastrointestinal pathology, or those on specific diets or medications that could interfere with the study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the treatment and management of autism by addressing gut health and its impact on brain function.
How similar studies have performed: While the gut-brain axis has been studied in relation to various neurological conditions, this specific investigation into the interplay of intestinal dysbiosis and BBB integrity in ASD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Child from the ELENA cohort who received at least 3 years of follow-up in this cohort and a diagnosis of ASD * Aged 6 to 16 years * Living in Languedoc-Roussillon * Consent to participate in the study signed by the legal representative Exclusion criteria: * Syndromic autism (neuroanatomical abnormality detected on brain MRI, severe neurological syndrome or polymalformative) * Known severe gastrointestinal pathology (such as celiac disease or Crohn's disease) * Other known severe chronic disease (e.g., diabetes) * Specific diet (gluten-free, casein-free, ketogenic, protein-enriched) within 6 months * Antibiotics taken within 2 months prior to inclusion * Probiotics taken in the 6 months prior to inclusion * Oxytocin intake in the 6 months prior to inclusion * ADOS Level Module 4 (due to the impossibility of calculating a ADOS-CSS score in this case) * Not affiliated to a French social security scheme or not beneficiaries of such a scheme * Refusal of blood test * Pregnant women
Where this trial is running
Montpellier
- Centre de Ressources Autisme — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Stéphanie MIOT, MD-PH — Montpellier University Hospital
- Study coordinator: Stéphanie MIOT, MD-PhD
- Email: s-miot@chu-montpellier.fr
- Phone: 467339687
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.