Probiotics and Autism: Another Clinical Trial

Several times before I have mentioned that the best studied probiotic in the world is Visbiome (the new name for the formulation that used to go by the name VSL#3).  Look here and here, as just a couple of examples. Over 70 clinical studies have utilized it.  Over this past weekend, I spotted the results of a new study conducted on children with autism.[i]  As I have written about many times, those with autism suffer substantially more GI issues (4x more often than non-autistic people) as well as marked differences in the gut biome.

This study was conducted in Italy, and Visbiome’s effects were evaluated in both those with GI problems and those without, in a 6-month long, double-blind, placebo-controlled trial, as compared to a control group.  63 subjects, preschoolers, completed the study.  The researchers were looking for improvements in behavior, measurable by a variety of tests and autism rating scales.  Secondarily, they were looking for improvements in GI symptoms.  One group received high doses of Visbiome, 900 billion organisms, for the first month, and then 450 billion for the next 5 months of the study.  (Remember how often I have commented on the incredibly low doses used in some clinical studies and in most probiotic formulations?!)

The results showed a decrease in the core ASD symptoms in both the children with GI symptoms and those without, although this did not reach statistical significance.  That said, the findings overall are still highly meaningful.  When the probiotic-treated group without GI symptoms was compared to those who were given the placebo, there was a significant difference:  those who received the probiotic had a reduction in their total autism score, especially in their social-affect score, compared to the placebo group.  In the group of children with GI symptoms, the probiotic group showed statistically significant improved compared to the placebo group on GI symptoms and in adaptive functioning and multi-sensory processing.  No adverse events were reported in any group.

What has scientists around the world worked up is that the probiotic had statistically significant beneficial effect on children without GI symptoms as well:  “These results suggest potentially positive effects of probiotics on core autism symptoms in a subset of ASD children independent of the specific intermediation of the probiotic effect on GI symptoms.”[ii]

The authors note that their study suggests that the different effects on the two groups (i.e. with and without GI symptoms) may indicate that the probiotic is working via distinct, and as yet unknown, mechanisms. They found no differences in the levels of inflammatory biomarkers in the experimental groups versus placebos, and suggest that this may well mean that the probiotics work via mechanisms other than pure inflammation, like gut barrier permeability, immunomodulation and restoration of altered gut flora, as has been found in other studies.

Overall, the study was positive, and I was pleased to see it.  As always though, the thought that goes through my head is, “What were these kids eating?”  Of course, in such an experiment, only 1 factor can be controlled so this is not a negative comment on this work.  It’s simply that in my own experience, having witnessed more than once dramatic improvements in the core symptoms of autism in children on the combination of Visbiome and VSL#3 along with the Specific Carbohydrate Diet, I can’t help but wonder what would happen in a clinical study to children with ASD given these kinds of doses of probiotics combined with an improved diet.



[ii] Santocchi E. et al. Effect of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. Frontiers in Psychiatry. 2020; 11:550593.

2 Comments on “Probiotics and Autism: Another Clinical Trial

  1. What do these folks recommend for someone tending towards diarrhea? Someone who can’t do more than 30 B, due to that?

    • Hi. They make no recommendations – they are simply reporting the results of a clinical trial as am I.

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