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Could a probiotic ease autism gut troubles?

NCT ID NCT06568588

Symptom relief Sponsor: Universidad San Francisco de Quito Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a probiotic called Saccharomyces boulardii can improve digestive health, immune function, nutrition, and behavior in children aged 5 to 12 with autism and a history of gut problems. Sixty-six children in Ecuador will take the probiotic for 4 months and then stop for 4 months, with researchers tracking changes through stool, blood, and urine samples, as well as behavior and intelligence tests. The goal is to see if this simple supplement can make a real difference in their daily lives.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Saccharomyces boulardii (a probiotic)
What this could lead to
If it works, this could point toward a simple probiotic supplement to ease digestive symptoms and possibly improve behavior in children with autism.
What could go wrong
This is a small Phase 2 trial with only 66 children, so results may not apply to everyone. The probiotic may not cause meaningful changes, and any benefits might be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder

Contacts and locations

Locations

  • Neurodesarrollo Quito

    Quito, Pichincha, Ecuador

More trials for these conditions

Other studies related to the condition(s) this trial covers.