Longitudinal Adaptive Functioning Outcomes in Children with Autism Spectrum Disorder During a 180 Day Open-Label...

Area of Science:

• Neuroscience
• Gastroenterology
• Pediatrics

Background:

• Autism spectrum disorder (ASD) often presents with gastrointestinal issues and immune system alterations.
• Altered gut microbiota signaling is implicated in ASD, prompting research into microbiota-targeted therapies.

Purpose of the Study:

• To evaluate the long-term effects of K11-TMAX on adaptive functioning in children with ASD.
• To assess improvements in communication, daily living skills, socialization, and motor skills.

Main Methods:

• An open-label extension study involving 130 children (3-11 years) with ASD, following a prior randomized controlled trial.
• Participants received K11-TMAX (kefir-derived probiotic + micronutrients) for over 180 days.
• Adaptive functioning assessed using Vineland-3, including the Adaptive Behavior Composite (ABC) and four core domains.

Main Results:

• All participants showed significant improvements across all assessed adaptive functioning parameters (effect sizes 0.13-0.43).
• The placebo to K11-TMAX group showed the most significant communication gains.
• The continuous K11-TMAX group exhibited the greatest reduction in externalizing behaviors.

Conclusions:

• K11-TMAX supplementation led to clinically meaningful improvements in adaptive functioning for children with ASD.
• While beneficial, improvements remained within the disability range, not reaching typical developmental levels.
• Findings suggest K11-TMAX may be a useful adjunct therapy for ASD by modulating the gut-brain axis.