Double-blind, controlled and randomised study with a parallel group design on the effect of formula feeding (IF and FOF) supplemented with a mixture of immunological active neutral and acidic oligosaccharides on the incidence of febrile respiratory and gastrointestinal infections in healthy term born infants during the first year of life.

Not Applicable

• Conditions: Healthy, term born infants not at high risk to develop an atopic disease; Z38.2; Z38.5; J00-J06; J20; J22; J01; Singleton, unspecified as to place of birth; Twin, unspecified as to place of birth; Acute upper respiratory infections

• Registration Number: DRKS00000201
• Lead Sponsor: Danone Research (former NUMICO Research Germany)Clinical Studies Platform

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2009-04-22
• Study Start: 2009-09-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1187

Inclusion Criteria

healthy, term born infants (GA 37-42 weeks)
-normal birth weight (girls: 2.7-5.0 kg, boys: 2.9-5.2 kg)
-not older than 8 weeks of age when entering the study,
-not at high risk to develop an atopic disease which would require the feeding of an HA formula with hydrolysed protein according to current recommendations
- no metabolic disorders requiring a special diet other than standard non-hydrolyzed IF/FOF

Exclusion Criteria

-Mothers suffering from hepatitis B, HIV or GBS
-Mothers taking antibiotics during breastfeeding
-Infants with known congenital diseases or malformations which would interfere with the study, e.g. gastrointestinal malformations, congenital or acquired immunodeficiency, etc.
-Study pre-feedings of the infants which could interfere with the study, e.g. non-cow?s milk based formulas, HA formulas, probiotic formulas, etc.
-Infants with actual or previous illnesses which could interfere with the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of febrile episodes during the 1st year of life

Secondary Outcome Measures

Name	Time	Method
-Symptoms of illnesses indicating a viral or bacterial infection <br>-Occurrence of allergic symptoms with focus on the skin (atopic dermatitis)<br>-Biochemical blood/plasma parameters of immune status, at least in a subgroup of infants <br>-Parameters of gut health, immune status and inflammation, at least in a subgroup of infants<br>-Anthropometric parameters<br>-Parameters of safety, acceptance, tolerance and gastrointestinal discomfort