NCT06568588Active, not recruitingPhase 2
Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD)
Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD) in the Metropolitan District of Quito, Ecuador
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- 6 Jan 2024
- Primary completion date
- Aug 2026
- Lead sponsor
- Universidad San Francisco de Quito
- Diseases
- Autism
- NCT number
- NCT06568588
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From 6 Jan 2024 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics, systemic steroids or antifungal medication during the last 15 days prior to fecal sample collection.
- Probiotics consumption in the last three months prior to study enrollment.
- Simultaneous participation in clinical studies, or in exclusion periods of a previous clinical study.
Other illness
- Severe chronic comorbidities such as cancer, immunosuppression, obstructive respiratory disorders, Crohn's disease, ulcerative colitis, among others, at the discretion of the investigators.
- History of allergy or hypersensitivity to Saccharomyces boulardii or its components, or allergy to yeasts.
Other
- Acute gastrointestinal, respiratory or febrile processes.
- Contraindication and special warning to Saccharomyces boulardii according to the technical Data Sheets, including central venous catheter carriers.
Who the study is looking for
- 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.
Age in the registry: 5 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurodesarrollo Quito Coordinator of this site? Confirm its status | Quito | Ecuador | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.