NCT03710551

Happy Smooth Study

Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 21 Days – 28 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Detailed description

Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Conditions

• Infant Term Birth

Interventions

Type	Name	Description
OTHER	Experimental Infant Formula	Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum
OTHER	Standard Infant Formula	Standard bovine milk-based infant formula, fed ad libitum

Timeline

• Start date: 2018-09-26
• Primary completion: 2019-06-21
• Completion: 2019-07-21
• First posted: 2018-10-18
• Last updated: 2021-02-21

Locations

1 site across 1 country: Philippines