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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03514784
Other study ID # HSC-MS-17-0995
Secondary ID R01HD095158-02
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2016
Est. completion date December 2025

Study information

Verified date May 2024
Source The University of Texas Health Science Center, Houston
Contact J. Marc Rhoads, MD
Phone 713-500-7642
Email j.marc.rhoads@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Other known NCT identifiers
  • NCT02674984

Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 16 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
BB-12 with LGG (Higher Dose)
BB-12 with LGG - Higher Dose (10 billion CFUs)
Placebo
Maltodextrin
BB-12 with LGG (Lower Dose)
BB-12 with LGG - Lower Dose (1 billion CFUs)

Locations

Country Name City State
United States UTHealth Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Texas Higher Education Coordinating Board

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Effects of BB-12+LGG at different doses on GI symptoms as measured by GI Symptom Severity Index GI symptoms will be measured by the GI Severity Index. Days 1, 21, 56 and 84
Other Effects of BB-12+LGG at different doses on gut inflammation (S1009A) Plasma S100A9 will indicate GI and systemic levels of inflammation. S100A9 is a damage-associated molecular pattern molecule (DAMP) released by granulocytes, which is reportedly elevated 2-fold in plasma of children with ASD. Days 1, 56 and 84
Other Effects of BB-12+LGG at different doses on gut inflammation (Fecal Calprotectin) Biological change in fecal calprotectin levels. FC is a highly accurate fecal marker of inflammation. Days 1, 56 and 84
Other Effects of BB-12+LGG at different doses on gut inflammation (Plasma Zonulin) Plasma zonulin, a marker for intestinal permeability ("leaky gut"), which is often associated with inflammation. Days 1, 56 and 84
Other Effects of BB-12+LGG at different doses on gut inflammation (IL-8) IL-8 can be an indicator of gut inflammation; it released from the intestinal epithelial cells during inflammation. Days 1, 56 and 84
Other Effects of BB-12+LGG at different doses on fecal microbial community Using 16S rDNA analysis, this will determine microbial alpha and beta diversity and distribution of the major taxa before and after probiotic treatment. Days 1, 56 and 84
Other Effects of BB-12+LGG at different doses on metabolites This will determine levels of metabolic markers which are reported to be abnormal in autism: fecal amino acids, ammonia, short chain fatty acids (SCFA), and phenols. Days 1, 56 and 84
Primary 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 Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC) Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the Aberrant Behavior Checklist (ABC) pre and post treatment Days 1, 21, 56 and 84
Secondary Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors measured with the Social Responsiveness Scale-2 Psychological/Behavioral change in irritability and related maladaptive behaviors associated with ASD will be measured by the and the Social Responsiveness Scale-2 (SRS-2) pre and post treatment. Days 1, 21, 56 and 84
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