Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396689
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-10
Brief Title:
NapBiome Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
Sponsor:
Petra Zimmermann
Organization:
University of Fribourg
Study Overview
Official Title:
NapBiome Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NapBiome
Brief Summary:
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes The first year of life is a critical period for the development of the gut microbiome which parallels important milestones in establishing sleep rhythm and neurodevelopment Growing evidence suggests that the gut microbiome influences sleep cognition and early neurodevelopment For term and preterm-born infants difficulties in sleep regulation can have major consequences on infants health attachment between infants and their caregivers and can even lead to life-threatening consequences such as shaken-baby syndrome Preterm born infants are at even higher risk for sleep and neurodevelopmental problems Although neonatal care has improved over recent decades preterm birth rates continue to rise and lead to a wide range of neurodevelopmental disabilities that are unaddressed with current therapies Given the importance of sleep and the gut microbiome for brain maturation neurodevelopment and behavior identifying effective interventions within the gut-brain axis at the beginning of life is likely to have long-term implications for health and development of at-risk infants
The aims of this project are to I demonstrate the association between the gut microbiome sleep patterns and health outcomes in children up to two years of age and II to leverage gut microbiome-brain-sleep interactions to develop new intervention strategies for at-risk infants The investigators hypothesize that the establishment of a healthy gut microbiome during early life is crucial for both short- and long-term child health outcomes as dysbiosis can harm sleep regulation brain maturation and neurobehavioral development The investigators predict that the administration of synbiotics improves microbiota establishment sleep rhythm and neurodevelopmental outcomes
This project integrates a randomized controlled trial RCT ex vivo and in silico experiments with I key technology platforms for computational modeling to capture the ontogenic norms of gut microbiota II neuronal and actimetry-based quantification of multidimensional aspects of infant sleep III breath metabolomics exhalomics of host and microbiome metabolism and IV high-throughput ex vivo models for investigating host-microbiome interactions Outcomes include I an understanding of age-normative microbiome composition its variation circadian inter-individual and the factors that influence the microbiomes plasticity throughout infancy II actionable knowledge of microbial species and metabolism that can be targeted to modify sleep regulation and improve neurodevelopmental outcomes especially in at-risk infants eg preterm-born III microbial and metabolic biomarkers with diagnostic potential for later regulatory and behavioral problems and IV an open-source analytical toolbox for microbial multi-omics that can be immediately applied in other areas of microbiome-host research To achieve these goals our strategy combines multiple disciplines focusing on factors that exert the greatest influence on health during infancy the gut microbiome sleep regulation and neurodevelopment
The impact of this project is substantial and globally relevant as it advances possible treatment options for supporting neurodevelopmental health in preterm- and term-born infants explores novel translational approaches for addressing regulatory difficulties and provides key information for tailored prophylactic synbiotics and possible development of post-biotics Further the study supports the investigation of biomarkers for neurodevelopment and advances early prevention of developmental and mental illnesses
The aims of this project are to I demonstrate the association between the gut microbiome sleep patterns and health outcomes in children up to two years of age and II to leverage gut microbiome-brain-sleep interactions to develop new intervention strategies for at-risk infants The investigators hypothesize that the establishment of a healthy gut microbiome during early life is crucial for both short- and long-term child health outcomes as dysbiosis can harm sleep regulation brain maturation and neurobehavioral development The investigators predict that the administration of synbiotics improves microbiota establishment sleep rhythm and neurodevelopmental outcomes
This project integrates a randomized controlled trial RCT ex vivo and in silico experiments with I key technology platforms for computational modeling to capture the ontogenic norms of gut microbiota II neuronal and actimetry-based quantification of multidimensional aspects of infant sleep III breath metabolomics exhalomics of host and microbiome metabolism and IV high-throughput ex vivo models for investigating host-microbiome interactions Outcomes include I an understanding of age-normative microbiome composition its variation circadian inter-individual and the factors that influence the microbiomes plasticity throughout infancy II actionable knowledge of microbial species and metabolism that can be targeted to modify sleep regulation and improve neurodevelopmental outcomes especially in at-risk infants eg preterm-born III microbial and metabolic biomarkers with diagnostic potential for later regulatory and behavioral problems and IV an open-source analytical toolbox for microbial multi-omics that can be immediately applied in other areas of microbiome-host research To achieve these goals our strategy combines multiple disciplines focusing on factors that exert the greatest influence on health during infancy the gut microbiome sleep regulation and neurodevelopment
The impact of this project is substantial and globally relevant as it advances possible treatment options for supporting neurodevelopmental health in preterm- and term-born infants explores novel translational approaches for addressing regulatory difficulties and provides key information for tailored prophylactic synbiotics and possible development of post-biotics Further the study supports the investigation of biomarkers for neurodevelopment and advances early prevention of developmental and mental illnesses
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None