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

U

University of Guadalajara

Status

Enrolling

Conditions

Autism Spectrum Disorder

Treatments

Other: Gluten free and casein free diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06556290
CI- 01624

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Nutritional Intervention
Experimental group
Description:
Group with 3 months of a gluten free and casein free diet
Treatment:
Other: Gluten free and casein free diet

Trial contacts and locations

1

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Central trial contact

Nora M. Torres Carrillo, Ph.D.; Priscila I. Ibarra Montero, Ph.D.Student

Data sourced from clinicaltrials.gov

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