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Article

Longitudinal Adaptive Functioning Outcomes in Children with Autism Spectrum Disorder During a 180 Day Open-Label Extension of K11-Tmax, a Consortium Probiotic Mix with Multivitamins

by
Deivis O. Guimaraes
1,2,*,
Racire S. Silva
3,
Lara A. Ferreira
3,
Larissa Martinelli
3,
Rebeca M. M. Werly
3,
Raphaela F. Amorim
1,
Lívia B. S. S. Holzbach
1,
Roberto Badaró
2,
Alex A. B. Santos
2,
Elisardo C. Vasquez
3 and
Sarha A. L. de Queiroz
3
1
Gon1 Biotech, Vitória City 29050-335, Espirito Santo State, Brazil
2
PPG-GETEC: Industrial Management and Technology, Senai Cimatec University, Salvador 41650-010, Bahia, Brazil
3
Translational Physiology and Pharmacology Laboratory, Graduate Program in Pharmaceutical Sciences, Vila Velha University, Vila Velha 29102-920, Espirito Santo State, Brazil
*
Author to whom correspondence should be addressed.
Life 2026, 16(6), 940; https://doi.org/10.3390/life16060940
Submission received: 22 April 2026 / Revised: 19 May 2026 / Accepted: 28 May 2026 / Published: 2 June 2026
(This article belongs to the Section Microbiology)
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Abstract

Autism spectrum disorder (ASD) is frequently associated with gastrointestinal symptoms, immune dysregulation, and altered microbiota-related signaling, supporting interest in microbiota-targeted interventions. This study evaluated adaptive functioning for over 180 days in children with ASD in a previously randomized controlled trial (RCT). After the initial 90-day blinded phase, the study continued as an open-label extension (OLE) in which all participants received K11 TMAX, a kefir-derived probiotic consortium combined with a microencapsulated micronutrient blend. The study included 130 children (3–11 years of age) who continued from the RCT were followed-up in three different trajectories: (1) placebo → K11-TMAX; (2) K11 → K11-TMAX; and (3) continued K11-TMAX supplementation. Children’s adaptive functioning was assessed by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3), Adaptive Behavior Composite (ABC) as well as by four core domains: (1) communication; (2) daily living skills; (3) socialization; and (4) motor skills. All three groups of children improved significantly on all of the parameters that were assessed with the effect sizes ranging from 0.13 to 0.43. The greatest improvement in the communication domain was seen in the transition group (1) and the greatest decrease in the externalizing behavior scores were seen in the continuous group (3) of children. Children’s adaptive functioning improved in clinically meaningful ways. Children’s improvement, however, was within the disability range and did not reach the level of typical development of children of the same age. These findings suggest supplementary therapeutic use of K11-TMAX, modulating the gut–brain axis, in children with autism spectrum disorder (ASD).
Keywords: autism spectrum disorder; probiotics; kefir; gut–brain axis; adaptive behavior; Vineland-3; longitudinal study; open-label extension autism spectrum disorder; probiotics; kefir; gut–brain axis; adaptive behavior; Vineland-3; longitudinal study; open-label extension

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MDPI and ACS Style

Guimaraes, D.O.; Silva, R.S.; Ferreira, L.A.; Martinelli, L.; Werly, R.M.M.; Amorim, R.F.; Holzbach, L.B.S.S.; Badaró, R.; Santos, A.A.B.; Vasquez, E.C.; et al. Longitudinal Adaptive Functioning Outcomes in Children with Autism Spectrum Disorder During a 180 Day Open-Label Extension of K11-Tmax, a Consortium Probiotic Mix with Multivitamins. Life 2026, 16, 940. https://doi.org/10.3390/life16060940

AMA Style

Guimaraes DO, Silva RS, Ferreira LA, Martinelli L, Werly RMM, Amorim RF, Holzbach LBSS, Badaró R, Santos AAB, Vasquez EC, et al. Longitudinal Adaptive Functioning Outcomes in Children with Autism Spectrum Disorder During a 180 Day Open-Label Extension of K11-Tmax, a Consortium Probiotic Mix with Multivitamins. Life. 2026; 16(6):940. https://doi.org/10.3390/life16060940

Chicago/Turabian Style

Guimaraes, Deivis O., Racire S. Silva, Lara A. Ferreira, Larissa Martinelli, Rebeca M. M. Werly, Raphaela F. Amorim, Lívia B. S. S. Holzbach, Roberto Badaró, Alex A. B. Santos, Elisardo C. Vasquez, and et al. 2026. "Longitudinal Adaptive Functioning Outcomes in Children with Autism Spectrum Disorder During a 180 Day Open-Label Extension of K11-Tmax, a Consortium Probiotic Mix with Multivitamins" Life 16, no. 6: 940. https://doi.org/10.3390/life16060940

APA Style

Guimaraes, D. O., Silva, R. S., Ferreira, L. A., Martinelli, L., Werly, R. M. M., Amorim, R. F., Holzbach, L. B. S. S., Badaró, R., Santos, A. A. B., Vasquez, E. C., & de Queiroz, S. A. L. (2026). Longitudinal Adaptive Functioning Outcomes in Children with Autism Spectrum Disorder During a 180 Day Open-Label Extension of K11-Tmax, a Consortium Probiotic Mix with Multivitamins. Life, 16(6), 940. https://doi.org/10.3390/life16060940

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