Impact of a gluten and casein-free diet on children with autism
Effect of a Casein and Gluten Free Diet on Gastrointestinal Symptoms, Clinical Variables and Gut Microbiota Composition in Mexican Children With Autism Spectrum Disorder
This study tests whether a gluten and casein-free diet can improve gut health and other symptoms in Mexican children with autism over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | University of Guadalajara Academic / other |
| Locations | 1 site (Guadalajara, Jalisco) |
| Trial ID | NCT06556290 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a gluten-free and casein-free diet on gastrointestinal symptoms, clinical variables, and the intestinal microbiota in Mexican children diagnosed with autism spectrum disorder. It employs a quasi-experimental pre-post design with time series, where participants will follow the dietary intervention for three months. Clinical evaluations and sample collections will be conducted before and after the intervention to assess changes in health outcomes.
Who should consider this trial
Good fit: Ideal candidates are Mexican children aged 4-10 years diagnosed with autism spectrum disorder.
Not a fit: Patients with celiac disease, gluten-related disorders, or those allergic to dairy products may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved gastrointestinal health and overall clinical outcomes for children with autism spectrum disorder.
How similar studies have performed: While dietary interventions for autism have been explored, this specific approach focusing on a gluten and casein-free diet in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guadalajara, Jalisco
- Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara — Guadalajara, Jalisco, Mexico (Recruiting)
Study contacts
- Principal investigator: Nora M. Torres Carrillo, Ph.D. — University of Guadalajara
- Study coordinator: Nora M. Torres Carrillo, Ph.D.
- Email: nora.torres@academicos.udg.mx
- Phone: 523310585200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.