NCT03514784CompletedPhase 1/2
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann. Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology \& Microbiology of Baylor College of Medicine.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 26 Jan 2018
- Start date
- May 2016
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- Autism
- NCT number
- NCT03514784
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 100
- From May 2016 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects taking immunosuppressive medications, including oral corticosteroids
Other illness
- A History of Positive result of HIV, Hepatitis B, and/or Hepatitis C test
- Gastrointestinal diseases such as celiac disease, inflammatory bowel disease
- Subjects with an allergy to antibiotics
- Acute diarrheal illness within the past 30 days
- Subjects with implanted prosthetic devices including prosthetic heart valves
Other
- Pregnancy or breastfeeding
- Abnormal lab test results (Section 5.2)
- Presence of fever or a pre-existing adverse event monitored in the study
- Use of probiotics in the last 30 days
- Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals Current use of oral laxatives
- The investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.
Who the study is looking for
- 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).
Age in the registry: 4 years to 16 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UTHealth Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.