Effect of a Casein and Gluten Free Diet in Mexican Children With Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gluten free and casein free diet.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Other 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.
Primary outcome measures
- Gut microbiota composition through Next Generation Sequencing (16SRNA) and bioinformatic analysis [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Mexico · 1 center
- Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara — Guadalajara
Identifiers
NCT: NCT06556290 · CI- 01624