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Could a probiotic ease autism symptoms? new study investigates

NCT ID NCT03514784

Symptom relief Sponsor: The University of Texas Health Science Center, Houston 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tested a probiotic (BB-12 with LGG) in 123 children with autism and stomach problems. The goal was to see if different doses are safe and can improve behavior and gut health. Researchers tracked side effects, behavior changes, and gut bacteria over 56 days of treatment plus 28 days of follow-up.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

100 people

The number who actually took part.

Started

May 2016

Finished

Jul 2025

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

4 to 16 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy children with autism spectrum disorders (4 - 16 years old) and gastrointestinal symptoms, based on the GI Severity Index, with no other recognized illness will be enrolled in this study. There will be no selection on the basis of age, race, or gender. Although the investigators anticipate the majority of subjects will be male and/or pre-pubertal, in females of childbearing potential, a pregnancy test (urine) will be performed on females participating (at each visit). Exclusion Criteria: * Pregnancy or breastfeeding * Subjects taking immunosuppressive medications, including oral corticosteroids * A History of Positive result of HIV, Hepatitis B, and/or Hepatitis C test * Abnormal lab test results (Section 5.2) * Gastrointestinal diseases such as celiac disease, inflammatory bowel disease * Subjects with an allergy to antibiotics * Presence of fever or a pre-existing adverse event monitored in the study * Use of probiotics in the last 30 days * Acute diarrheal illness within the past 30 days * Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals Current use of oral laxatives * Subjects with implanted prosthetic devices including prosthetic heart valves * The investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder constipation disorder diarrheal disease

As listed by the trial registrant

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

Autism spectrum disorder Gastrointestinal symptoms

Contacts and locations

Locations

  • UTHealth

    Houston, Texas, 77030, United States

More trials for these conditions

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