NCT01861600

Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 7 Days – 14 Days
• Healthy volunteers: Accepted

Summary

The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.

Detailed description

The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition and characteristics and to investigate the effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool softness and bacteria. Because some studies demonstrate the benefit of high concentrations of a non-digestible carbohydrate in the formula, we will study 2 concentrations of added oligofructose.

Conditions

• Stool Composition

Interventions

Type	Name	Description
OTHER	S-26 Gold	(13.4 g/L protein) with 100% Fat Blend A
OTHER	S-26 Gold EF1	(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend
OTHER	S-26 Gold EF2	(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose
OTHER	S-26 Gold EF3	(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose
OTHER	Human Milk	Human Milk

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2013-05-23
• Last updated: 2013-05-23

Locations

1 site across 1 country: Philippines