Probiotics for Quality of Life in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders; Anxiety
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder
      (ASD), targeting gastrointestinal (GI) symptoms.
    

Detailed description: 
      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.
    

Intervention name(s): Maltose (placebo); Visbiome Extra Strength
Intervention type(s): Drug; Drug
Intervention description(s): Maltose with a trace amount of silicon dioxide; It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
Other intervention name(s): Maltose with silicon dioxide
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gastrointestinal Microbiome