Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder

NCT03514784 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: HSC-MS-17-0995R01HD095158-02
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder; Gastrointestinal Symptoms

Keywords

Autism Spectrum Disorder, ASD, Gastrointestinal Symptoms, Constipation, Diarrhea

Outcome Measures

Primary Outcomes (1)

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

  Adverse events (Safety) will be measured by case report form (survey) that are related to BB-12 with LGG (health-promoting bacteria) or placebo treatment. The symptom grade will detail the severity of adverse events.

  84 days

Secondary Outcomes (2)

• Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)

  Days 1, 21, 56 and 84

• Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors measured with the Social Responsiveness Scale-2

  Days 1, 21, 56 and 84

Other Outcomes (7)

• Effects of BB-12+LGG at different doses on GI symptoms as measured by GI Symptom Severity Index

  Days 1, 21, 56 and 84

• Effects of BB-12+LGG at different doses on gut inflammation (S1009A)

  Days 1, 56 and 84

• Effects of BB-12+LGG at different doses on gut inflammation (Fecal Calprotectin)

  Days 1, 56 and 84

Study Arms (3)

BB-12 with LGG (Lower Dose)

ACTIVE COMPARATOR

BB-12 with LGG (Multistrain probiotic; lower dose): 1 billion CFUs

Drug: BB-12 with LGG (Lower Dose)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Drug: Placebo

BB-12 with LGG (Higher Dose)

ACTIVE COMPARATOR

BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs

Drug: BB-12 with LGG (Higher Dose)

Interventions

BB-12 with LGG (Higher Dose) DRUG

BB-12 with LGG - Higher Dose (10 billion CFUs)

Also known as: Probiotic

BB-12 with LGG (Higher Dose)

Placebo DRUG

Maltodextrin

Also known as: Maltodextrin

Placebo

BB-12 with LGG (Lower Dose) DRUG

BB-12 with LGG - Lower Dose (1 billion CFUs)

Also known as: Probiotic

BB-12 with LGG (Lower Dose)

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• The University of Texas Health Science Center, Houston: lead
• Texas Higher Education Coordinating Board: collaborator

Study Sites (1)

UTHealth

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Constipation; Diarrhea

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• J Marc RHoads, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The head statistician and study pharmacist will be aware of randomization scheme. The investigators will use an adaptive minimization program for randomization that balances the 3 study arms with respect to distributions of sex and age (4-10 vs. 11-16 y.o.). Patients will be randomized to placebo, 1 billion CFU, and 10 billion CFU study arms at a ratio of 1:2:2. (Currently marketed over-the-counter probiotics typically contain 0.1-50 billion CFUs per dose.) The performance of our covariate adaptive randomization algorithm will be verified through simulation studies before implementation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: May 2, 2018
• Study Start: May 1, 2016
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)