Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06396689

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

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 microbiome's 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 (e.g., 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

0 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital cantonal Fribourg, Fribourg, Canton of Fribourg, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synbiotic

Dietary Supplement

The capsule contains Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, and Bifidobacterium bifidum R0071 (3 billion bacteria per capsule), as well as zinc oxide, potato starch fructooligosaccharides, coating agent, methyl hydroxypropyl cellulose, anti-caking agent and magnesium stearat

Placebo

Dietary Supplement

The capsule contains zinc oxide, coating agent, methyl hydroxypropyl cellulose, anti-caking agent and magnesium stearat

Primary outcomes

  1. Sleep-wake behavior

    Time frame: up to two years of age

    Brief Infant Sleep Questionnaire BISQ, actinometry and sleep-wake diary

  2. Neuronal connectivity

    Time frame: up to two years of age

    High-density EEG during sleep

  3. Neurobehavioral development

    Time frame: up to two years of age

    Bayley Scales of Infant Development

  4. Behavior

    Time frame: up to two years of age

    Infant Behavior Questionnaire

  5. Gut microbiota

    Time frame: up to two years of age

    Composition of stool microbiota

  6. Stool metabolome

    Time frame: up to two years of age

    Composition of stool metabolites

  7. Breath metabolome

    Time frame: up to two years of age

    Composition of breath metabolites

Secondary outcomes

  1. Eczema

    Time frame: up to two years of age

    SCORing Atopic Dermatitis scoring system (SCORAD)

  2. Food allergy

    Time frame: up to two years of age

    Skin prick test

  3. Rates of infection

    Time frame: up to two years of age

    Number of episodes

  4. Breast milk microbiota

    Time frame: up to two years of age

    Composition investigated trough shotgun metagenomic sequencing

  5. Nasal microbiota

    Time frame: up to two years of age

    Composition investigated trough shotgun metagenomic sequencing

  6. Oral microbiota

    Time frame: up to two years of age

    Composition investigated trough shotgun metagenomic sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Zimmermann, MD, PhD

CONTACT

[email protected]

+412063060000

Sponsors and collaborators

Lead sponsor

Petra Zimmermann

Other

Collaborators

  • Swiss Federal Institute of Technology in Zurich (ETHZ)
  • University of Luzern

Registry information

Acronym: NapBiome

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 2, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.