Effect of a Casein and Gluten Free Diet in Mexican Children With Autism Spectrum Disorder

Last updated: August 13, 2024
Sponsor: University of Guadalajara
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Asperger's Disorder

Autism

Treatment

Gluten free and casein free diet

Clinical Study ID

NCT06556290
CI- 01624
  • Ages 4-10
  • All Genders

Study Summary

Assess the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Children between 4-10 years old diagnosed with autism spectrum disorder using the criteria established in the ADOS scale and the CARS.

Exclusion

Exclusion Criteria:

Children who have received:

  • Antibiotics

  • Antimycotics

  • Probiotic supplements

  • Prebiotic supplements

  • Any medication that may alter the microbial composition of the patient, minimum onemonth prior to sampling.

  • Children on a strict dietary regimen other than a casein-free and gluten-free diet.

  • Children with celiac disease or who present any gluten-related disorder.

  • Children with allergy to dairy products.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Gluten free and casein free diet
Phase:
Study Start date:
February 12, 2024
Estimated Completion Date:
July 31, 2025

Study Description

The objective of this quasi-experimental pre-post study with time series is to evaluate the effect of a casein-free and gluten-free diet on gastrointestinal symptoms, clinical variables, and the composition of the intestinal microbiota in Mexican children with autism spectrum disorder. The main question it aims to answer is:

Does a casein free and gluten free diet promote a reduction in gastrointestinal symptoms, an improvement in clinical variables, and a state of eubiosis in the composition of the intestinal microbiota in Mexican children with autism spectrum disorder?

Participants will undergo:

An intervention of a casein-free and gluten-free diet for 3 months. Sample collection before and after the nutritional intervention. Clinical evaluations.

Connect with a study center

  • Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

    Guadalajara, Jalisco 44340
    Mexico

    Active - Recruiting

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