A study based on a mix of probiotics selected according to 5 criteria

A study is currently ongoing in Italy. Enrolling 100 autistic patients aged 18 to 72 months, it aims to measure the effectiveness of a 6 month supplementation of the multi-strain high concentration probiotic blend Vivomixx. The evaluation criteria for this study focus on the severity of autistic behaviors, gastrointestinal symptoms and the encephalogram of patients.

The implementation of this new study is based on criteria of efficacy and safety of use of this mix of bateria that have demonstrated in previous clinical studies and give hope for improvement in this complex disorder.

1. Selection of strains by objective criteria

• selection of 8 probiotic strains with specific and defined functional and metabolic properties, measurable by objective criteria.
• controlled manufacturing process
• evaluation carried out on the final mix and not on the separated strains (synergistic action of the mix demonstrated)

2. Combination of strains with proven synergistic efficacy

• for example, concerning gluten sensitivity, one study demonstrated that the multi-strain probiotic mix contained in Vivomixx® completely hydrolyzes certain epitopes of gliadin while individually the same strains contained in this mix have been significantly less effective in causing hydrolysis.

3. Safety of use

• the probiotic mix which has been shown to be effective in many clinical studies to control onset and prevent relapses of pouchitis and ulcerative colitis, with a high safety profile allowing for the product to be introduced into the gastroenterology guidelines in different Countries (European Crohn and Colitis Organization for example).
• Proven effective to improve pain and bloating associated with functional colopathy or irritable bowel syndrome, including in children and teenagers for whom there is no effective pharmacological treatment.

4. Proven action on the brain-gut axis

• the Enteric Nervous System (ENS) is also known as the “brain of the gut” and its dysregulation plays a major role in the pathogenesis of functional abdominal pain.
• neonatal stress, such as maternal separation, modifies the serotonergic, dopaminergic and noradrenergic systems and modifies the expression of genes in the colon tissue. In mice, exposure to an early stress stimulus changes the expression of about one-third of the entire genome, most of which is grouped under the “metabolism” category (proteins and carbohydrates).
• The use of this specific probiotic mix was capable of reversing the alterations induced by the separation of the mother, including those involved in the “pain” and “inflammation” categories. This specific bacterial mix helps to restore the intestinal microbiota and gene expression at the local level.

5. Anti-inflammatory action (inflammation and microglia)

• Neuroinflammatory processes play a major role in inducing changes in autistic behavior. Microglial cells have very different functions during brain development from birth and their activation or dysfunction can strongly affect neural development and cause neurodevelopmental disorders including autism
• these mechanisms have been extensively studied and have confirmed the harmful role that microglia can play in the development of autism.
• it appears that the anti-inflammatory activity of the probiotic observed in the intestine extends towards the brain.

Reference *Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters
Details of this ongoing study available in English on Clinical Trials.gov (USA)