NapBiome: Targeted Influence on the Gut Microbiome and Sleep Cycle to Improve Development in Early Childhood
Résumé de l'étude
The collaboration between the gut and the brain plays a crucial role in regulating and developing many processes in the body, including early neurodevelopment. There is increasing evidence that the gut microbiome also affects sleep and cognitive functions. Particularly in the first two years of life, a critical developmental phase, the microbiome changes rapidly. Disruptions during this phase can lead to long-term health problems. Premature infants are especially at risk of suffering from sleep and developmental issues. Despite improved neonatal care, the rates of premature births continue to rise. Therefore, it is important to find effective preventive measures and therapies. In our NapBiome study, we investigate how the administration of synbiotics (beneficial gut bacteria including food for them) improves the sleep and neurological development of term and preterm infants.
(BASEC)
Intervention étudiée
Administration of Synbiotics = dietary supplements that are intended to improve both probiotics (good bacteria) and prebiotics (food for these bacteria) and the gut microbiome
(BASEC)
Maladie en cours d'investigation
Sleep Problems Psychomotor Development
(BASEC)
Children can participate if they are born during the study period at the Freiburg Hospital HFR in Fribourg or at the Cantonal Hospital in Lucerne. Your child is eligible to participate in the study if they are born after the 32nd week of pregnancy, are fully or partially breastfed, and have not taken probiotics so far. (BASEC)
Critères d'exclusion
Low Birth Weight Severe Illness Use of Probiotics Before Study Participation (BASEC)
Lieu de l’étude
Fribourg, Luzern
(BASEC)
Sponsor
Kantonsspital Luzern LUKS
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Petra Zimmermann
+4126 300 94 77
petra.zimmermann@clutterunifr.chUniversity of Fribourg
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
25.06.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06396689 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
NapBiome: Targeting gut microbiota and sleep rhythm to improve developmental and behavioral outcomes in early childhood (BASEC)
Titre académique
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood (ICTRP)
Titre public
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood (ICTRP)
Maladie en cours d'investigation
Sleep ProblemNeurobehavioral Manifestations (ICTRP)
Intervention étudiée
Dietary Supplement: SynbioticDietary Supplement: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Sleep-wake behavior;Neuronal connectivity;Neurobehavioral development;Behavior;Gut microbiota;Stool metabolome;Breath metabolome (ICTRP)
Breast milk microbiota;Nasal microbiota;Oral microbiota;Eczema;Food allergy;Rates of infection (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
University of Luzern;Swiss Federal Institute of Technology in Zurich (ETHZ) (ICTRP)
Contacts supplémentaires
Petra Zimmermann, MD, PhD;Martin Stocker, MD, petra.zimmermann@unifr.ch; martin.stocker@luks.ch, +412063060000;+4141 205 32 31 (ICTRP)
ID secondaires
123 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06396689 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible