Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD)
NCT Number: NCT06568588
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Autism Spectrum Disorder
Interventions: DRUG: S. boulardii CNCM (National Collection of Cultures of Microorganisms) I-745
Sponsor: Universidad San Francisco de Quito
Collaborators: Biocodex|Neurodesarrollo Quito|University of Illinois at Urbana-Champaign
Sex: ALL
Age: CHILD
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-06
Completion Date: 2025-01
Locations: Neurodesarrollo Quito, Quito, Pichincha, Ecuador

Summary:
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.

Primary Outcome Measures: Modifications of gastrointestinal symptoms during Sb administration, 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+., Gastrointestinal symptoms will be evaluated monthly, through study completion, an average of 1 year|Modifications of gastrointestinal microbiota during Sb administration, 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., Fecal samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.|Modifications of fecal metabolome during Sb administration, 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., Fecal samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.|Modifications of blood metabolome during Sb administration, 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., Blood samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.|Modifications of urine metabolome during Sb administration, 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., Urine samples will be analyzed at months 1, 4, 5, 9 and 10 of the study.|Modifications of body mass index (BMI) during Sb administration, 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., BMI will be determined at months 1, 4, 5, 9 and 10 of the study.|Modifications of nutrient intake during Sb administration, Changes in the nutrient intake of children with ASD when they are receiving Sb supplementation. The 24-hour reminder questionnaire will be applied to quantify nutrient intake., Nutrient intake will be determined at months 1, 4, 5, 9 and 10 of the study.|Modifications of immune function during Sb administration, Changes in the immune function of children with ASD when they are receiving Sb supplementation. Levels of interleukins and growth factors will be determined. Specifically, interleukin(IL)-1, IL-4, IL-6, IL-8, tumoral necrosis factor (TNF) -α, interferon (IFN)-γ, IL-10, transforming growth factor (TGF)-β will be measured., Blood samples for interleukins and growth factors determination will be analyzed at months 1,4, 5, 9,10 of the study|Modifications of behavior during Sb administration, Changes in the behavior of children with ASD when they are receiving Sb supplementation. ADOS- 2 test will be applied to determine conduct in different situations, sensory response and adaptive functioning. The total scores range from 15 to 60, and a higher score means a worse outcome., ADOS-2 test will be performed at months 1, 4, 5, 9, 10 of the study.|Modifications in the intelligence levels during Sb administration, Changes in the intelligence levels of children with ASD when they are receiving Sb supplementation. Different tests will be used according to the age and language level of the participants. WISC will be used on children from 7 years 4 months of age. WPPSI will be applied to children 7 years 3 months or younger. BATTELLE will be used for children 8 years old or younger who have a low language level. With all of these tests, a higher score means a better outcome., Tests will be performed at months 1, 4, 5, 9, 10 of the study.