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

Autism Spectrum Disorder Clinical Trial

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Gastrointestinal Symptoms

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