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Study details
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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take BB-12 with LGG (Higher Dose)
  • 2.Take BB-12 with LGG (Lower Dose)
  • 3.Take Placebo
PhasePhase 1/Phase 2
Primary goalEffects of BB-12+LGG at different doses on adverse events (safety)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

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

Body systems

Psychiatry / Mental Health