# Road to discovery for combination probiotic BB-12 with LGG in treating autism spectrum disorder

> **NIH NIH R01** · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · 2022 · $418,632

## Abstract

Project Abstract
Road to discovery for Combination Probiotic Strain: BB-12 with LGG in treating
autism spectrum disorders
Stomach problems are common in children with autism. The proposed research project will
study children with autism spectrum disorders (ASD), 4-15 years of age, who are complaining of
recurring gastrointestinal (GI) symptoms, such as abdominal pain, constipation, and vomiting.
These gastrointestinal problems are often associated with abnormal behavior, such as
irritability. Our group is planning to test if at two different doses of a probiotic (defined as a
bacterial product which when consumed in adequate quantity improves health) can benefit
these children with GI symptoms. Oral doses of the probiotic we have selected (Lactobacillus
rhamnosus GG and Bifidobacterium lactis BB-12, BB-12+LGG) to be tested are: a straw with 2
billion colony forming units (CFUs), a straw with 10 billion CFUs, and a placebo straw. We plan
to enroll 70 eligible subjects with confirmed ASD and randomize them to placebo, low dose, and
high dose of BB-12+LGG once daily at 1:2:2 ratio. The probiotic, to be added to food, may
improve abdominal complaints which we hypothesize may produce changes in autistic behaviors
that accompany these GI symptoms.
Even though probiotics are widely available, the U.S. Food and Drug Administration requires
that we demonstrate that this particular combination probiotic is safe in children before we can
undertake a large multi-center trial to see if BB-12+LGG is effective at different doses in
children with ASD. Based on previous trials in adults and adolescents, we expect no serious side
effects from the use of BB-12+LGG. There will be 4 visits over 90 days. We expect to see a trend
toward improvement of autistic behavior and GI symptoms by the end of the 56 days of
treatment with BB-12+LGG at the highest dose. The pain and abnormal behaviors will be
recorded using validated questionnaires.
This study incorporates an Integrated Omics approach. Several blood and stool tests will be
tested as potentially useful biomarkers of intestinal health in ASD, including a test of gut
permeability (zonulin), a blood test for systemic inflammation (S100A9), and a stool test for
inflammation (calprotectin). We will concomitantly measure bacterial communities in the stool
(using 16S ribosomal DNA sequencing) and we will measure key metabolites in the blood and
stool that have been proposed to contribute to GI symptoms in children with ASD (using high
performance liquid chromatography). If an optimal dose of BB-12 + LGG is found to be safe and
shows a signal toward improvement with respect to GI or autistic symptoms, we plan to study
this probiotic in a larger, multi-center trial, using adaptive trial design.

## Key facts

- **NIH application ID:** 10439571
- **Project number:** 5R01HD095158-04
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
- **Principal Investigator:** JON Marc RHOADS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $418,632
- **Award type:** 5
- **Project period:** 2018-08-20 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10439571

## Citation

> US National Institutes of Health, RePORTER application 10439571, Road to discovery for combination probiotic BB-12 with LGG in treating autism spectrum disorder (5R01HD095158-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10439571. Licensed CC0.

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