Autism Spectrum DisorderPhase 1/2NCT03514784
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
A Phase 1/2 study testing BB-12 with LGG (Higher Dose) and BB-12 with LGG (Lower Dose) in people with Autism Spectrum Disorder and Gastrointestinal Symptoms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Gastrointestinal Symptoms
- What is being tested?
- BB-12 with LGG (Higher Dose) and BB-12 with LGG (Lower Dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 30 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders
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.
- Being tested
- BB-12 with LGG (Higher Dose), Placebo, BB-12 with LGG (Lower Dose)
- Keywords
- Autism Spectrum Disorder, ASD, Gastrointestinal Symptoms, Constipation, Diarrhea
- Medical subject headings
- Autism Spectrum Disorder, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-12 with LGG (Higher Dose)Drug
Also called Probiotic
BB-12 with LGG - Higher Dose (10 billion CFUs)
PlaceboDrug
Also called Maltodextrin
Maltodextrin
BB-12 with LGG (Lower Dose)Drug
Also called Probiotic
BB-12 with LGG - Lower Dose (1 billion CFUs)
| Study group | Role | What they receive |
|---|---|---|
| BB-12 with LGG (Lower Dose) | Active comparator | BB-12 with LGG (Multistrain probiotic; lower dose): 1 billion CFUs Receives: Drug: BB-12 with LGG (Lower Dose) |
| Placebo | Placebo comparator | Maltodextrin Receives: Drug: Placebo |
| BB-12 with LGG (Higher Dose) | Active comparator | BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs Receives: Drug: BB-12 with LGG (Higher Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Indicated by Number of Participants With Invasive Infection Resulting From the Administration of Probiotic
Infection will be determined by clinical observations and temperature measurements made during the study period, as well as complete metabolic panel, complete blood count, and C-reactive protein (CRP) blood testing.
Measured: from baseline to 56 days
Number of Participants With Clinical Tolerance of the Probiotic
Tolerance will be determined by assessment of symptoms, which will be monitored at clinical research center visits, as well as ability to remain on the treatment.
Measured: from baseline to 56 days
Safety as Indicated by Number of Participants With Toxicity Resulting From the Administration of Probiotic
Toxicity will be determined by assessment of electrolyte status, renal function [blood urea nitrogen (BUN) and creatinine (Cr), hepatic toxicity [transaminases (AST, ALT) and total bilirubin], and hematologic status [CBC to measure hemoglobin and absolute neutrophil count].
Measured: from baseline to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study startMay 2016
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After psychological screening, the subjects will be randomize children to one of 3 groups. The total number of subject to be enrolled will be 70 healthy children with confirmed ASD status, randomizing each child to placebo (maltodextrin), low daily dose (1 billion cfu's), and higher daily dose (10 billion cfu's) of BB-12+LGG once daily at 1:2:2 ratio. Data will be combined with 30 patients obtained from two funding sources: Texas (THECB) and U.T. pilot project. The data will be combined and an identical design of the placebo and 1 billion cfu dose arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Higher Education Coordinating Board, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, J. Marc Rhoads, The University of Texas Health Science Center, Houston
- Investigators
- J Marc RHoads, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514784
- Sponsor's protocol ID
- HSC-MS-17-0995
- Other IDs
- R01HD095158-02
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2018
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders
- ClinicalTrials.gov ID
- NCT03514784
- Acronym / sponsor ID
- HSC-MS-17-0995
- Keywords
- Autism Spectrum Disorder, ASD, Gastrointestinal Symptoms, Constipation, Diarrhea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Texas Higher Education Coordinating Board, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2016 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- After psychological screening, the subjects will be randomize children to one of 3 groups. The total number of subject to be enrolled will be 70 healthy children with confirmed ASD status, randomizing each child to placebo (maltodextrin), low daily dose (1 billion cfu's), and higher daily dose (10 billion cfu's) of BB-12+LGG once daily at 1:2:2 ratio. Data will be combined with 30 patients obtained from two funding sources: Texas (THECB) and U.T. pilot project. The data will be combined and an identical design of the placebo and 1 billion cfu dose arms.
| Arm | Type | Receives |
|---|---|---|
| BB-12 with LGG (Lower Dose) | Active comparator | Drug: BB-12 with LGG (Lower Dose)BB-12 with LGG (Multistrain probiotic; lower dose): 1 billion CFUs |
| Placebo | Placebo comparator | Drug: PlaceboMaltodextrin |
| BB-12 with LGG (Higher Dose) | Active comparator | Drug: BB-12 with LGG (Higher Dose)BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB-12 with LGG (Higher Dose)Also: ProbioticBB-12 with LGG - Higher Dose (10 billion CFUs) | Drug | BB-12 with LGG (Higher Dose) |
| PlaceboAlso: MaltodextrinMaltodextrin | Drug | Placebo |
| BB-12 with LGG (Lower Dose)Also: ProbioticBB-12 with LGG - Lower Dose (1 billion CFUs) | Drug | BB-12 with LGG (Lower Dose) |
Primary outcome
Safety as Indicated by Number of Participants With Invasive Infection Resulting From the Administration of Probiotic
Time frame: from baseline to 56 days
Infection will be determined by clinical observations and temperature measurements made during the study period, as well as complete metabolic panel, complete blood count, and C-reactive protein (CRP) blood testing.
Number of Participants With Clinical Tolerance of the Probiotic
Time frame: from baseline to 56 days
Tolerance will be determined by assessment of symptoms, which will be monitored at clinical research center visits, as well as ability to remain on the treatment.
Safety as Indicated by Number of Participants With Toxicity Resulting From the Administration of Probiotic
Time frame: from baseline to 56 days
Toxicity will be determined by assessment of electrolyte status, renal function [blood urea nitrogen (BUN) and creatinine (Cr), hepatic toxicity [transaminases (AST, ALT) and total bilirubin], and hematologic status [CBC to measure hemoglobin and absolute neutrophil count].
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Marc RHoads, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BB-12 with LGG (Higher Dose) and BB-12 with LGG (Lower Dose) in people with Autism Spectrum Disorder and Gastrointestinal Symptoms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as Indicated by Number of Participants With Invasive Infection Resulting From the Administration of Probiotic (time frame: from baseline to 56 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.