Status:
RECRUITING
Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD)
Lead Sponsor:
Universidad San Francisco de Quito
Collaborating Sponsors:
Biocodex
Neurodesarrollo Quito
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
Brief 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...
Detailed Description
Autism Spectrum disorder (ASD), is a group of neurodevelopmental abnormalities that begin in early childhood, frequently characterized by problems in communication and social behavior. Metabolites pro...
Eligibility Criteria
Inclusion
- Diagnostic of Autistic Spectrum Disorders (ASD).
- History of gastrointestinal (GI) disorders, recurrent diarrhea, during the past 6 months.
- Children attending learning or therapy centers or schools.
- Age between 5 and 12 years of age.
- Children whose parents or guardians consent their participation in the study.
- Children who can provide the required biological samples, and their guardians must provide the necessary information to complete the established instruments.
- The parents or guardians of the children must sign the informed consent form in order to be part of the study.
Exclusion
- Use of antibiotics, systemic steroids or antifungal medication during the last 15 days prior to fecal sample collection.
- Acute gastrointestinal, respiratory or febrile processes.
- Severe chronic comorbidities such as cancer, immunosuppression, obstructive respiratory disorders, Crohn's disease, ulcerative colitis, among others, at the discretion of the investigators.
- Probiotics consumption in the last three months prior to study enrollment.
- History of allergy or hypersensitivity to Saccharomyces boulardii or its components, or allergy to yeasts.
- Contraindication and special warning to Saccharomyces boulardii according to the technical Data Sheets, including central venous catheter carriers.
- Simultaneous participation in clinical studies, or in exclusion periods of a previous clinical study.
Key Trial Info
Start Date :
January 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06568588
Start Date
January 6 2024
End Date
August 1 2026
Last Update
December 15 2025
Active Locations (1)
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1
Neurodesarrollo Quito
Quito, Pichincha, Ecuador