RecruitingPhase 1Phase 2NCT03514784

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

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

70 participants

Start Date

May 1, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination probiotic — containing Bifidobacterium BB-12 and Lactobacillus GG (LGG) — can reduce gastrointestinal (GI) symptoms in children with autism spectrum disorder (ASD). Many children with autism experience significant gut problems including constipation, diarrhea, bloating, and abdominal pain, which can worsen behavioral symptoms and overall wellbeing. Researchers believe the gut-brain connection may be especially relevant in ASD, and that restoring a healthy gut microbiome could help. The study is open to healthy children aged 4 to 16 who have been diagnosed with ASD and who have current GI symptoms. Two different doses of the probiotic combination are being tested, and the study will track both GI symptom changes and any side effects. You may be eligible if: - Your child is between 4 and 16 years old - Your child has a diagnosis of autism spectrum disorder - Your child has current gastrointestinal symptoms - Your child is otherwise healthy (no recognized co-morbid illness) You may NOT be eligible if: - Your child is pregnant or breastfeeding - Your child takes immunosuppressive medications or oral corticosteroids - Your child has tested positive for HIV, Hepatitis B, or Hepatitis C - Your child has inflammatory bowel disease or celiac disease - Your child has had diarrhea within the past 30 days or taken antibiotics within 2 weeks - Your child has taken probiotic supplements in the past 30 days - Your child has a prosthetic heart valve or other implanted prosthetic device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBB-12 with LGG (Higher Dose)

BB-12 with LGG - Higher Dose (10 billion CFUs)

DRUGPlacebo

Maltodextrin

DRUGBB-12 with LGG (Lower Dose)

BB-12 with LGG - Lower Dose (1 billion CFUs)


Locations(1)

UTHealth

Houston, Texas, United States

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NCT03514784


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