RECRUITING

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

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Road to Discovery for Combination Probiotic BB-12 With LGG (Different Doses) in Treating Autism Spectrum Disorder Disorders

Quick Facts

Study Start:2016-05
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03514784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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).
  1. * Pregnancy or breastfeeding
  2. * Subjects taking immunosuppressive medications, including oral corticosteroids
  3. * A History of Positive result of HIV, Hepatitis B, and/or Hepatitis C test
  4. * Abnormal lab test results (Section 5.2)
  5. * Gastrointestinal diseases such as celiac disease, inflammatory bowel disease
  6. * Subjects with an allergy to antibiotics
  7. * Presence of fever or a pre-existing adverse event monitored in the study
  8. * Use of probiotics in the last 30 days
  9. * Acute diarrheal illness within the past 30 days
  10. * Recent (within 2 weeks) or current use of oral antibiotics /anti-fungals Current use of oral laxatives
  11. * Subjects with implanted prosthetic devices including prosthetic heart valves
  12. * The investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.

Contacts and Locations

Study Contact

J. Marc Rhoads, MD
CONTACT
713-500-7642
j.marc.rhoads@uth.tmc.edu
Nicole Fatheree, BBA
CONTACT
713-500-5669
nicole.fatheree@uth.tmc.edu

Principal Investigator

J Marc RHoads, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

UTHealth
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • J Marc RHoads, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05
Study Completion Date2025-12

Study Record Updates

Study Start Date2016-05
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Gastrointestinal Symptoms