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

NCT06556290 | Recruiting DMC

• 1 other identifier: CI- 01624
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Gut microbiota; Gluten free diet; Casein free diet

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks

Study Arms (1)

Nutritional Intervention

EXPERIMENTAL

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

Other: Gluten free and casein free diet

Interventions

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.

Nutritional Intervention

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nora M. Torres Carrillo, Ph.D.

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora M. Torres Carrillo, Ph.D.

CONTACT

523310585200; nora.torres@academicos.udg.mx

Priscila I. Ibarra Montero, Ph.D.Student

CONTACT

523310585200; priscila.ibarra2303@alumnos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PH.D. In Biomedical Sciences, Tenured Research Professor A

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 16, 2024
• Study Start: February 12, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)