Actively Recruiting
Intestinal Dysbiosis and BBB Integrity in Autism
Led by University Hospital, Montpellier · Updated on 2024-05-29
60
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Autism Spectrum Disorder (ASD) is characterised by an impairment of social interactions and communication, associated with repetitive behaviour and restrictive interests. Clinical phenotypes of this neurodevelopmental disorder are heterogeneous and surprisingly up to 70% of ASD patients have gastro-intestinal (GI) disorders, associated with ASD severity and influence by feeding disorders. Gut-brain axis seems to play a key role in neurodevelopment and ASD pathophysiology. Indeed an intestinal dysbiosis is observed in ASD, as well as intestinal inflammation and permeability. Aspecific inflammatory pattern suggests neuroinflammation processes in ASD. Neuroinflammation is involved in blood brain barrier (BBB) integrity and there are some arguments for a putative BBBimpairment in ASD. Nevertheless, no study has explored all together these parameters in ASD patients. Here we hypothesise that intestinal dysbiosis in ASD could lead to a BBB impairment through neuroinflammation processes. Furthermore, this association between intestinal dysbiosis and BBB impairment could be influenced by a lot of clinical characteristics, such as ASD severity or GI disorders presence. The principal aim of our study is to determine if the gut microbiota composition is associated with the BBB integrity in ASD. The secondary objectives are i) too identify in children with ASD some physiopathological pathways involved in this association, with a focus on associations betweenintestinal dysbiosis, intestinal permeability, intestinal permeability, the Th1/Th2 immune response, neuroinflammation and the BBB integrity; ii) to evaluate the influence of these associations on several clinical features of ASD such as ASD severity or GI disorders intensity; iii) to evaluate the influence of nutritional status on biological and clinical parameters. This study will assess a lot of clinical and biological parameters together, some of them were never explored in ASD children. It will allow to better understand ASD pathophysiology, to highlight new therapeutic pathway, and to promote personalised medicine.
CONDITIONS
Official Title
Intestinal Dysbiosis and BBB Integrity in Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child from the ELENA cohort with at least 3 years of follow-up and a diagnosis of Autism Spectrum Disorder
- Aged 6 to 16 years
- Living in Languedoc-Roussillon
- Legal representative has signed consent to participate
You will not qualify if you...
- Syndromic autism with neuroanatomical abnormalities, severe neurological syndromes, or multiple malformations
- Known severe gastrointestinal diseases such as celiac disease or Crohn's disease
- Other severe chronic diseases like diabetes
- Following a specific diet (gluten-free, casein-free, ketogenic, protein-enriched) within the last 6 months
- Antibiotics use within 2 months prior to inclusion
- Probiotics use within 6 months prior to inclusion
- Oxytocin intake within 6 months prior to inclusion
- ADOS Level Module 4 (unable to calculate ADOS-CSS score)
- Not covered by French social security
- Refusal to have blood test
- Pregnant women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre de Ressources Autisme
Montpellier, France, 34295
Actively Recruiting
Research Team
S
Stéphanie MIOT, MD-PhD
CONTACT
A
Amaria BAGHDADLI, PU-PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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