Purpose

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

Eligibility

Eligible Ages
Between 4 Years and 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
BB-12 with LGG (Lower Dose)
BB-12 with LGG (Multistrain probiotic; lower dose): 2 billion CFUs
  • Drug: BB-12 with LGG (Lower Dose)
    BB-12 with LGG - Lower Dose (1 billion CFUs)
    Other names:
    • Probiotic
Placebo Comparator
Placebo
Maltodextrin
  • Drug: Placebo
    Maltodextrin
    Other names:
    • Maltodextrin
Active Comparator
BB-12 with LGG (Higher Dose)
BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs
  • Drug: BB-12 with LGG (Higher Dose)
    BB-12 with LGG - Higher Dose (10 billion CFUs)
    Other names:
    • Probiotic

Recruiting Locations

UTHealth
Houston, Texas 77030
Contact:
Jon M Rhoads, M.D.
713-500-5669
j.marc.rhoads@uth.tmc.edu

More Details

NCT ID
NCT03514784
Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

J. Marc Rhoads, MD
713-500-7642
j.marc.rhoads@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.