Gut Microbiota, Antipsychotics, and Metabolic Alterations in Children and Adolescents: Protocol for a Longitudinal Observational Study

JMIR Res Protoc. 2025 Dec 29;14:e77374. doi: 10.2196/77374.

ABSTRACT

BACKGROUND: Over the past decade, numerous studies have emphasized the important role of gut microbiota (GM) in maintaining the body’s homeostasis. Imbalances in GM have been linked to many dysfunctions, such as metabolic and neurodevelopmental disorders. GM can be influenced by many factors, among them the use of certain medications, such as second-generation antipsychotics (SGAs), and, in turn, act upon the endocrine, immune, and nervous systems. Despite the growing interest in the microbiota-gut-brain axis, significant gaps remain in our understanding of how SGAs affect GM and the host metabolic profile.

OBJECTIVE: This study aims to build on the current knowledge on the impact of SGAs on clinical parameters, microbial and metabolic profiles, and behavior of children and adolescents undergoing treatment with SGAs.

METHODS: This is a prospective longitudinal study, in which the effects of SGAs will be assessed before and 3 to 6 months after their introduction. An integrated approach will be used, encompassing clinical data (such as weight, lipid profile, and glucose levels); microbiome and metabolome analyses; emotional, behavioral, and sleep patterns (assessed through psychiatric scales); and dietary habits.

RESULTS: This project was funded in November 2023 and will start data collection in January 2026. It is expected to be completed in 2027.

CONCLUSIONS: This study is expected to provide insights into the multidimensional effects of SGAs on children and adolescents, including clinical data, GM microbial profile, metabolism, and behavior. The findings may contribute to a better understanding of treatment impacts and provide information on more personalized therapeutic strategies.

PMID:41461105 | DOI:10.2196/77374