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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06556290
Enrollment
20
Registered
2024-08-16
Start date
2024-02-12
Completion date
2025-07-31
Last updated
2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Gut microbiota, Gluten free diet, Casein free diet

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.

Interventions

OTHERGluten 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.

Sponsors

University of Guadalajara
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis12 weeksThe composition of the intestinal microbiota will be sequenced, and gastrointestinal symptoms will be characterized before and after the nutritional intervention.

Countries

Mexico

Contacts

Primary ContactNora M. Torres Carrillo, Ph.D.
nora.torres@academicos.udg.mx523310585200
Backup ContactPriscila I. Ibarra Montero, Ph.D.Student
priscila.ibarra2303@alumnos.udg.mx523310585200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026