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NCT Number: NCT06556290

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

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.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location status: Recruiting

Location contact

Jose L. Acosta Rodríguez, Ph.D

SUB_INVESTIGATOR

Nora M. Torres Carrillo, Ph.D.

CONTACT

[email protected]

523310585200 ext. 33768

Priscila I. Ibarra Montero, Ph.D.Student

CONTACT

[email protected]

523310585200 ext. 33768

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gluten free and casein free diet

Other

Parents will be advised for three months to ensure that children with autism spectrum disorder follow a casein-free and gluten-free diet during this period.

Primary outcomes

  1. Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis

    Time frame: 12 weeks

    The composition of the intestinal microbiota will be sequenced, and gastrointestinal symptoms will be characterized before and after the nutritional intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Nora M. Torres Carrillo, Ph.D.

CONTACT

[email protected]

523310585200 ext. 33768

Priscila I. Ibarra Montero, Ph.D.Student

CONTACT

[email protected]

523310585200 ext. 33768

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study title

Effect of a Casein and Gluten Free Diet on Gastrointestinal Symptoms, Clinical Variables and Gut Microbiota Composition in Mexican Children With Autism Spectrum Disorder

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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