Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers

NAActive, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

Conditions
Gastrointestinal Tolerance of Probiotics in Infants
Interventions
DIETARY_SUPPLEMENT

Synbiotic Supplement

Participants will be given 1g of a synbiotic product each day, containing 4 microbial strains isolated from an infant gut (total of 1 billion cfu) and a mixture of 4 human milk oligosaccharides. Parents will administer the product by dissolving in breast milk, formula, or water, or mixing with food.

DIETARY_SUPPLEMENT

Lactose (inactive placebo)

Participants will be given 1g of lactose as a placebo. Parents will administer the product by dissolving in breast milk, formula, or water, or mixing with food.

Trial Locations (1)

92121

Persephone Biosciences, San Diego

Sponsors
All Listed Sponsors
lead

Persephone Biosciences

INDUSTRY

NCT06746285 - Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers | Biotech Hunter | Biotech Hunter