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

NCT ID: NCT06556290

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nutritional Intervention

Group with 3 months of a gluten free and casein free diet

Group Type EXPERIMENTAL

Gluten free and casein free diet

Intervention Type 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.

Interventions

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Gluten free and casein free diet

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Guadalajara

OTHER

Sponsor Role lead

Responsible Party

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Nora Magdalena Torres Carrillo

PH.D. In Biomedical Sciences, Tenured Research Professor A

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nora M. Torres Carrillo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

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Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Nora M. Torres Carrillo, Ph.D.

Role: CONTACT

523310585200 ext. 33768

Priscila I. Ibarra Montero, Ph.D.Student

Role: CONTACT

523310585200 ext. 33768

Facility Contacts

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Nora M. Torres Carrillo, Ph.D.

Role: primary

523310585200 ext. 33768

Priscila I. Ibarra Montero, Ph.D.Student

Role: backup

523310585200 ext. 33768

Other Identifiers

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CI- 01624

Identifier Type: -

Identifier Source: org_study_id

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