Actively Recruiting

Phase Not Applicable
Age: 6Years - 16Years
All Genders
NCT04321915

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

Age: 6Years - 16Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Intestinal Dysbiosis and BBB Integrity in Autism | DecenTrialz