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

Phase 1

Recruiting

• Conditions: Autism Spectrum Disorder; Gastrointestinal Symptoms
• Interventions: Drug: BB-12 with LGG (Lower Dose); Drug: BB-12 with LGG (Higher Dose); Drug: Placebo

• Registration Number: NCT03514784
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BB-12 with LGG (Lower Dose)	BB-12 with LGG (Lower Dose)	BB-12 with LGG (Multistrain probiotic; lower dose): 1 billion CFUs
BB-12 with LGG (Higher Dose)	BB-12 with LGG (Higher Dose)	BB-12 with LGG (Multistrain probiotic: higher dose): 10 billion CFUs
Placebo	Placebo	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Effects of BB-12+LGG at different doses on adverse events (safety)	84 days	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.

Secondary Outcome Measures

Name	Time	Method
Effects of BB-12+LGG at different doses on irritability and maladaptive behaviors with Aberrant Behavior Checklist (ABC)	Days 1, 21, 56 and 84	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
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	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.

Trial Locations

Locations (1)

UTHealth; 🇺🇸 Houston, Texas, United States