NapBiome: Targeted Influence on the Gut Microbiome and Sleep Cycle to Improve Development in Early Childhood
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Low Birth Weight Severe Illness Use of Probiotics Before Study Participation (BASEC)
Studienstandort
Freiburg, Luzern
(BASEC)
Sponsor
Kantonsspital Luzern LUKS
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Petra Zimmermann
+4126 300 94 77
petra.zimmermann@clutterunifr.chUniversity of Fribourg
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
25.06.2025
(BASEC)
ICTRP Studien-ID
NCT06396689 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
NapBiome: Targeting gut microbiota and sleep rhythm to improve developmental and behavioral outcomes in early childhood (BASEC)
Wissenschaftlicher Titel
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood (ICTRP)
Öffentlicher Titel
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood (ICTRP)
Untersuchte Krankheit(en)
Sleep ProblemNeurobehavioral Manifestations (ICTRP)
Untersuchte Intervention
Dietary Supplement: SynbioticDietary Supplement: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Luzern;Swiss Federal Institute of Technology in Zurich (ETHZ) (ICTRP)
Weitere Kontakte
Petra Zimmermann, MD, PhD;Martin Stocker, MD, petra.zimmermann@unifr.ch; martin.stocker@luks.ch, +412063060000;+4141 205 32 31 (ICTRP)
Sekundäre IDs
123 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06396689 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar