Ongoing Clinical Trial of Vivomixx Probiotic in Children with Autism

Since there is now interest in the potential benefit of probiotic bacteria to treat some autism, I wanted to point out that there actually is a clinical trial underway in Italy.  It is funded the Italian Ministry of Health and by the Tuscany Region.  They use Vivomixx, an OTC probiotic from the Italian speaking region of Switzerland.   

Vivomixx contains:

Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) 
lactobacilli (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracaseiDSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734).

Before you start wondering, it is not cheap; the Swiss do not do cheap.

There is a detailed explanation of the trial in the full version of the paper below.  It is due to be completed at the end of 2017.

  
Vivomixx is virtually identical to a well known expensive probiotic called VCL#3, which has been used in research.  Due to some dispute the originator of VCL#3 started a new company which now sells Vivomixx.  In some countries one is available and in other countries it is the other one.  VCL#3 is even more expensive. 

Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters

Background

A high prevalence of a variety of gastrointestinal (GI) symptoms is frequently reported in patients with Autism Spectrum Disorders (ASD). The GI disturbances in ASD might be linked to gut dysbiosis representing the observable phenotype of a “gut-brain axis” disruption. The exploitation of strategies which can restore normal gut microbiota and reduce the gut production and absorption of toxins, such as probiotics addition/supplementation in a diet, may represent a non-pharmacological option in the treatment of GI disturbances in ASD. The aim of this randomized controlled trial is to determine the effects of supplementation with a probiotic mixture (Vivomixx®) in ASD children not only on specific GI symptoms, but also on the core deficits of the disorder, on cognitive and language development, and on brain function and connectivity. An ancillary aim is to evaluate possible effects of probiotic supplementation on urinary concentrations of phthalates (chemical pollutants) which have been previously linked to ASD.

Methods

A group of 100 preschoolers with ASD will be classified as belonging to a GI group or to a Non-GI (NGI) group on the basis of a symptom severity index specific to GI disorders. In order to obtain four arms, subjects belonging to the two groups (GI and NGI) will be blind randomized 1:1 to regular diet with probiotics or with placebo for 6 months. All participants will be assessed at baseline, after three months and after six months from baseline in order to evaluate the possible changes in: (1) GI symptoms; (2) autism symptoms severity; (3) affective and behavioral comorbid symptoms; (4) plasmatic, urinary and fecal biomarkers related to abnormal intestinal function; (5) neurophysiological patterns.

Discussion

The effects of treatments with probiotics on children with ASD need to be evaluated through rigorous controlled trials. Examining the impact of probiotics not only on clinical but also on neurophysiological patterns, the current trial sets out to provide new insights into the gut-brain connection in ASD patients. Moreover, results could add information to the relationship between phthalates levels, clinical features and neurophysiological patterns in ASD.

Trial registration

ClinicalTrials.gov Identifier: NCT02708901. Retrospectively registered: March 4, 2016.

So in the coming years it looks like there will be some actual data with which you can decide whether or not to trial specific probiotic bacteria. 

Hopefully, the Biogaia people in Sweden will provide their products for some independent researchers to trial on humans with autism, probably Swedish ones.