NapBiome: Targeted Influence on the Gut Microbiome and Sleep Cycle to Improve Development in Early Childhood
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
Low Birth Weight Severe Illness Use of Probiotics Before Study Participation (BASEC)
Luogo dello studio
Friburgo, Luzern
(BASEC)
Sponsor
Kantonsspital Luzern LUKS
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Petra Zimmermann
+4126 300 94 77
petra.zimmermann@clutterunifr.chUniversity of Fribourg
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
25.06.2025
(BASEC)
ID di studio ICTRP
NCT06396689 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
NapBiome: Targeting gut microbiota and sleep rhythm to improve developmental and behavioral outcomes in early childhood (BASEC)
Titolo accademico
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood (ICTRP)
Titolo pubblico
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood (ICTRP)
Malattie studiate
Sleep ProblemNeurobehavioral Manifestations (ICTRP)
Intervento studiato
Dietary Supplement: SynbioticDietary Supplement: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Luzern;Swiss Federal Institute of Technology in Zurich (ETHZ) (ICTRP)
Contatti aggiuntivi
Petra Zimmermann, MD, PhD;Martin Stocker, MD, petra.zimmermann@unifr.ch; martin.stocker@luks.ch, +412063060000;+4141 205 32 31 (ICTRP)
ID secondari
123 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06396689 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile