Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD)
- Conditions
- Autism Spectrum Disorder
- Registration Number
- NCT06568588
- Lead Sponsor
- Universidad San Francisco de Quito
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Diagnostic of Autistic Spectrum Disorders (ASD).<br><br> - History of gastrointestinal (GI) disorders, recurrent diarrhea, during the past 6<br> months.<br><br> - Children attending learning or therapy centers or schools.<br><br> - Age between 5 and 12 years of age.<br><br> - Children whose parents or guardians consent their participation in the study.<br><br> - Children who can provide the required biological samples, and their guardians must<br> provide the necessary information to complete the established instruments.<br><br> - The parents or guardians of the children must sign the informed consent form in<br> order to be part of the study.<br><br>Exclusion Criteria:<br><br> - Use of antibiotics, systemic steroids or antifungal medication during the last 15<br> days prior to fecal sample collection.<br><br> - Acute gastrointestinal, respiratory or febrile processes.<br><br> - Severe chronic comorbidities such as cancer, immunosuppression, obstructive<br> respiratory disorders, Crohn's disease, ulcerative colitis, among others, at the<br> discretion of the investigators.<br><br> - Probiotics consumption in the last three months prior to study enrollment.<br><br> - History of allergy or hypersensitivity to Saccharomyces boulardii or its components,<br> or allergy to yeasts.<br><br> - Contraindication and special warning to Saccharomyces boulardii according to the<br> technical Data Sheets, including central venous catheter carriers.<br><br> - Simultaneous participation in clinical studies, or in exclusion periods of a<br> previous clinical study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modifications of gastrointestinal symptoms during Sb administration;Modifications of gastrointestinal microbiota during Sb administration;Modifications of fecal metabolome during Sb administration;Modifications of blood metabolome during Sb administration;Modifications of urine metabolome during Sb administration;Modifications of body mass index (BMI) during Sb administration;Modifications of nutrient intake during Sb administration;Modifications of immune function during Sb administration;Modifications of behavior during Sb administration;Modifications in the intelligence levels during Sb administration
- Secondary Outcome Measures
Name Time Method