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Autism Helped by Visbiome Probiotics

Probiotics for Quality of Life in Autism Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Ohio State University

Sponsor:
Ohio State University

Collaborators:
Autism Treatment Network
Autism Speaks

Information provided by (Responsible Party):
L. Eugene Arnold, Ohio State University

ClinicalTrials.gov Identifier:
NCT02903030
First received: June 14, 2016
Last updated: September 22, 2016
Last verified: September 2016
History of Changes

Purpose
The physical and mental/emotional health of people with autism spectrum disorder (ASD) are closely connected. The emerging data on immune abnormalities and gut microbiome differences, and interactions of the genome with these suggest a possible etiological link between physical and mental dysfunction, especially the gastrointestinal (GI) dysfunction and severe anxiety that many individuals with ASD manifest.

The investigators have preliminary clinical evidence that children with ASD & GI symptoms differ in microbiome composition and function from neurotypical children with GI symptoms.

The investigators hypothesize that altered host-microbial signals, which include altered fecal neurotransmitter gamma-aminobutyric acid (GABA) levels contribute towards anxiety and sensory over-responsivity in ASD.

Our preliminary findings also show that probiotic Visbiome Extra Strength, improves GI and pain symptoms, correlating with altered gut microbiome composition and related metabolites (the macrobiome).

The proposed crossover trial will explore the possibilities of this new appreciation of the microbiome-mental/physical function connection for ASD, GI dysfunction, and anxiety. If altering the gut microbiome results in better GI and emotional function, it could improve the quality of life for children with ASD and their parents.

A pilot trial with 12 children with ASD will test feasibility for a proposed three-site crossover randomized clinical trial (RCT) of probiotics (beneficial bacteria including Lactobacilli & Bifidobacteria) in 60 children 3-12 years old with ASD, GI dysfunction, & anxiety. In a balanced crossover children will be randomized 1;1 to Visbiome or placebo first, 8 weeks per condition with 3 weeks washout between.

The investigators have access to significant fecal microbiome and metabolome data from NIH-funded Human Microbiome Projects (HMP) on similar-age healthy and irritable-bowel children, with and without ASD. These will help leverage our understanding of macrobiome changes that correlate with functional improvement of GI and abdominal pain symptoms.

Pilot study efficiency will also benefit from those HMPs having already collected and analyzed baseline stools for some children with ASD, thus saving significant costs for baseline stool analyses for the pilot.

Study Status: This study is currently recruiting participants.
Estimated Study Completion Date: No date given
Estimated Primary Completion Date: August 2017
(Final data collection date for primary outcome measure)

Copyright © 2016 Good Gut Solution.

Dr. Pamela Nathan DHM October 13, 2016