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Could probiotics soothe tummies in kids with autism?

NCT ID NCT06352203

Disease control Sponsor: ProbiSearch SL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether a daily probiotic supplement can improve the balance of gut bacteria in children aged 3 to 7 who have autism and digestive issues like constipation or stomach pain. Over 6 months, 60 children will receive either the probiotic or a placebo. The main goal is to see if the probiotic helps restore a healthy gut microbiome.

What this could mean

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

Active substance
probiotic supplement
What this could lead to
If it works, this could point toward a way to improve gut health and possibly ease digestive symptoms in children with autism.
What could go wrong
This is a small, early-stage trial with only 60 children. It focuses on gut bacteria changes, not on core autism symptoms, so benefits may be limited to digestion.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

3 to 7 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: * Children aged 3 to 7 years old. * Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification. * Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence). * Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent. Exclusion Criteria: * With intake of antibiotics in the last month. * With intake of probiotics in the last two weeks. * Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract. * Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)). * Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc. * Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation). * Congenital or acquired immunodeficiency. * Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system). * Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol. * With oral hyper sensitivity impairments that prevent the uptake of the study product.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder neurodevelopmental disorder

As listed by the trial registrant

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

Neurodevelopmental disorders

Contacts and locations

Locations

  • Hospital Universitario Infantil Niño Jesús

    Madrid, Spain

More trials for these conditions

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