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NCT03514784 · ClinicalTrials.gov registry record · Phase 1
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
A Phase 1 study of Autism Spectrum Disorder and Gastrointestinal Symptoms, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT03514784 is a Phase 1 study of Autism Spectrum Disorder and Gastrointestinal Symptoms that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 70 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03514784, a Phase 1 study of Autism Spectrum Disorder and Gastrointestinal Symptoms, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BB-12 with LGG (Higher Dose)
- DRUG BB-12 with LGG (Lower Dose)
Study Locations (1)
Texas
- UTHealth - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-05 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03514784
The ClinicalTrials.gov registry entry for NCT03514784 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (48% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03514784 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03514784 about?
NCT03514784 is a clinical study titled "Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder". 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 an...
What is the current status of trial NCT03514784?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2016-05. Estimated completion is 2025-12.
What conditions does trial NCT03514784 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Gastrointestinal Symptoms.
What interventions are being tested in trial NCT03514784?
The interventions under investigation include: Placebo (DRUG), BB-12 with LGG (Higher Dose) (DRUG), BB-12 with LGG (Lower Dose) (DRUG).
Who is sponsoring clinical trial NCT03514784?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03514784 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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