NCT01983072

Symbiotic & Colonization

Effect of Starter Formula With Symbiotic on Microbiota Balance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 4 Months
• Healthy volunteers: Accepted

Summary

The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

Detailed description

The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Infant formula
OTHER	Breastfeeding	Breastfeeding

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2013-11-13
• Last updated: 2013-11-13

Locations

4 sites across 2 countries: France, Poland