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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Gluten free and casein free diet

• Registration Number: NCT06556290
• Lead Sponsor: University of Guadalajara

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-02-12
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 Criteria

Children who have received:

• Antibiotics
• Antimycotics
• Probiotic supplements
• Prebiotic supplements
• Any medication that may alter the microbial composition of the patient, minimum one month 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritional Intervention	Gluten free and casein free diet	Group with 3 months of a gluten free and casein free diet

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis	12 weeks	The composition of the intestinal microbiota will be sequenced, and gastrointestinal symptoms will be characterized before and after the nutritional intervention.

Trial Locations

Locations (1)

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico