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Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD) in the Metropolitan District of Quito, Ecuador
The goal of this clinical trial is to determine the effects of Saccharomyces boulardii (Sb) consumption on Ecuadorian children with a diagnosis of autism spectrum disorder (ASD) and digestive symptoms. Saccharomyces boulardii is a probiotic, in other words, a beneficial microorganism. The main question it aims to answer is: Does Sb improve intestinal health, defenses against infections, nutrition and behavior of the participants. Researchers will compare children when they are taking and not taking Saccharomyces boulardii to know if there are changes in digestive symptoms, immune system function, nutritional status and behavior. Participants will take Saccharomyces boulardii for 4 months and will be 4 months without taking Sb. All participants must provide stool, urine and blood samples. A medical, nutritional and psychological team will follow the participants at least 5 times during the study.
Details
| Lead sponsor | Universidad San Francisco de Quito |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 66 |
| Start date | 2024-01-06 |
| Completion | 2026-08 |
Conditions
- Autism Spectrum Disorder
Interventions
- S. boulardii CNCM (National Collection of Cultures of Microorganisms) I-745
Primary outcomes
- Modifications of gastrointestinal symptoms during Sb administration — Gastrointestinal symptoms will be evaluated monthly, through study completion, an average of 1 year
Changes in gastrointestinal symptoms of children with ASD when they are receiving Sb. Symptoms will be evaluated with Rome IV Pediatric Questionnaire Parent Report For Children and Adolescents Age 4+. - Modifications of gastrointestinal microbiota during Sb administration — Fecal samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.
Changes in alpha diversity, beta diversity, taxonomic composition, functional annotation and differential microbial relative abundance of gastrointestinal microbiota of children with ASD when they are receiving Sb supplementation. - Modifications of fecal metabolome during Sb administration — Fecal samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.
Changes in the fecal metabolome of children with ASD when they are receiving Sb supplementation. Metabolome will be determined with 2D experiments based on signals in H-NMR, using the human metabolome database and the biological magnetic resonance metabolome database. - Modifications of blood metabolome during Sb administration — Blood samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.
Changes in blood metabolome of children with ASD when they are receiving Sb supplementation. Metabolome will be determined with 2D experiments based on signals in H-NMR, using the human metabolome database and the biological magnetic resonance metabolome database. - Modifications of urine metabolome during Sb administration — Urine samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.
Changes in urine metabolome of children with ASD when they are receiving Sb supplementation. Metabolome will be determined with 2D experiments based on signals in H-NMR, using the human metabolome database and the biological magnetic resonance metabolome database. - Modifications of body mass index (BMI) during Sb administration — BMI will be determined at months 1, 4, 5, 9 and 10 of the study.
Changes in the BMI of children with ASD when they are receiving Sb supplementation. To obtain BMI, weight (in kilograms) and height (in meters) will be measured.
Countries
Ecuador