Skip to content
Study details
Enrolling now

Combination Probiotic Trial

The University of Texas Health Science Center, Houston
NCT IDNCT03514784ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

70

Study length

about 9.6 years

Ages

4–16

Locations

1 site in TX

What this study is about

This trial is testing a combination probiotic (BB-12 with LGG) at different doses in children with autism spectrum disorder and gastrointestinal symptoms. The goal is to see if the probiotic is safe and well-tolerated, as well as how it affects behaviors, GI symptoms, and biomarkers related to inflammation, gut bacteria, and metabolites.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take BB-12 with LGG (Higher Dose)
  • 2.Take BB-12 with LGG (Lower Dose)
  • 3.Take Placebo

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Effects of BB-12+LGG at different doses on adverse events (safety)

Body systems

Psychiatry / Mental Health