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

NANot yet recruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2029

Conditions
Sleep ProblemNeurobehavioral Manifestations
Interventions
DIETARY_SUPPLEMENT

Synbiotic

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

DIETARY_SUPPLEMENT

Placebo

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

Trial Locations (2)

1700

Hopital cantonal Fribourg, Fribourg

6000

Cantonal Hospital, Lucerne

All Listed Sponsors
collaborator

University of Luzern

OTHER

collaborator

Swiss Federal Institute of Technology in Zurich (ETHZ)

UNKNOWN

lead

Petra Zimmermann

OTHER

NCT06396689 - NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood | Biotech Hunter | Biotech Hunter