Effects of probiotics on children with autism
Effects of Probiotic Consumption in Children with Autism Spectrum Disorder (ASD) in the Metropolitan District of Quito, Ecuador
This study is testing if a probiotic called Saccharomyces boulardii can help improve gut health and behavior in Ecuadorian children with autism and digestive issues.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Universidad San Francisco de Quito Academic / other |
| Locations | 1 site (Quito, Pichincha) |
| Trial ID | NCT06568588 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of the probiotic Saccharomyces boulardii on Ecuadorian children diagnosed with autism spectrum disorder (ASD) and gastrointestinal symptoms. The study employs a randomized crossover design, where participants will alternate between taking the probiotic and a control period without it over eight months. Researchers will assess changes in digestive symptoms, immune function, nutritional status, and behavior through various biological samples and regular follow-ups by a medical team. The goal is to determine if probiotic supplementation can improve gut health and related outcomes in children with ASD.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 12 years with a diagnosis of autism spectrum disorder and a history of gastrointestinal disorders.
Not a fit: Patients with severe chronic comorbidities or recent use of certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gastrointestinal health and behavioral outcomes for children with autism spectrum disorder.
How similar studies have performed: While few studies have explored probiotics in children with ASD, existing research suggests potential benefits, making this approach both novel and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Quito, Pichincha
- Neurodesarrollo Quito — Quito, Pichincha, Ecuador (Recruiting)
Study contacts
- Principal investigator: Paúl A Cárdenas, PhD — Universidad San Francisco de Quito
- Study coordinator: Paúl A Cárdenas, PhD
- Email: pacardenas@usfq.edu.ec
- Phone: +593 2 297-1700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.