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Effects of Probiotic Consumption in Children With Autism Spectrum Disorder (ASD)

NCT06568588 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

S. boulardii CNCM (National Collection of Cultures of Microorganisms) I-745

250 mg three times a day for 4 months

Sponsors & Collaborators

  • Biocodex

    collaborator INDUSTRY

  • Neurodesarrollo Quito

    collaborator UNKNOWN

  • University of Illinois at Urbana-Champaign

    collaborator OTHER

  • Universidad San Francisco de Quito

    lead OTHER

Principal Investigators

  • Paúl A Cárdenas, PhD · Universidad San Francisco de Quito

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-06
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Ecuador

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568588 on ClinicalTrials.gov