Effects of Probiotic Consumption in Children with Autism Spectrum Disorder (ASD) in the Metropolitan District of Quito, Ecuador

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ecuador
Neurodesarrollo Quito
RECRUITING
Quito
Contact Information
Primary
Paúl A Cárdenas, PhD
pacardenas@usfq.edu.ec
+593 2 297-1700
Backup
Andrés Suárez-Jaramillo, MD, MSc
asuarezj@estud.usfq.edu.ec
+593987849083
Time Frame
Start Date: 2024-01-06
Estimated Completion Date: 2025-12
Participants
Target number of participants: 66
Treatments
Experimental: First four months with Sb (Group A)
Children that receive Sb supplements in the initial 4 months of the study.
Experimental: Last four months with Sb (Group B)
Children that receive Sb supplements in the final 4 months of the study.
Related Therapeutic Areas
Sponsors
Collaborators: Biocodex, Neurodesarrollo Quito, University of Illinois at Urbana-Champaign
Leads: Universidad San Francisco de Quito

This content was sourced from clinicaltrials.gov