NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood

Launched by PETRA ZIMMERMANN · Apr 29, 2024

Keywords

ClinConnect Summary

The NapBiome clinical trial is exploring how the gut microbiome—the community of bacteria in our intestines—affects sleep patterns and overall health in young children, particularly infants. Researchers believe that a healthy gut microbiome is essential for good sleep and brain development. They aim to understand how the gut microbiome is linked to sleep and behavior in infants up to two years old. The trial will also test if giving specific combinations of probiotics and prebiotics (known as synbiotics) can help improve sleep and development in infants, especially those who were born prematurely.

To participate in this study, infants need to be either preterm (born between 34 to 36 weeks of pregnancy) or term (born at 37 weeks or later) and must be partially breast-fed. However, some infants will not be eligible, including those with very low birth weights or certain health conditions. Families involved in the study can expect to help researchers learn more about the relationship between gut health and sleep, potentially leading to new ways to support healthy growth and development in infants. This research is important as it may offer new treatment options for infants struggling with sleep and developmental challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Preterm-arm:
• • neonates born between a gestational age of 34 0/7 to 36 6/7 weeks
• • partially breast-fed at the time of inclusion
• • Term-arm
• • neonates born at a gestational age of ≥ 37 0/7 weeks Infants need to be
• • partially breast-fed at the time of inclusion
• Exclusion Criteria:
• • Infants who
• • receive probiotics outside the trial design
• • have a birth weight \< 1500 g
• • were prenatally drug-exposed (cannabis, cocaine, heroin, opiates, and alcohol)
• • have suspected or confirmed immunodeficiency
• • have an underlying disease (excluding transient conditions such as alimentation problems, hyperbilirubinemia, hypoglycaemia, anemia, respiratory distress syndrome or apnea-bradycardia syndrome), congenital malformations, central nervous system disease or injury or congenital infections