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.

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. - MIPS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000201

Enrollment

1500

Registered

2009-09-09

Start date

2005-07-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, term born infants not at high risk to develop an atopic disease Z38.2 Z38.5 J00-J06 J20 J22 J01 A09

Interventions

Group 1: exclusive administration (full formula feeding) of a standard non-hydrolysed cow`s milk based formula containing an immunomodulating mix of neutral and acidic oligosaccharides at the latest

Eligibility

Sex/Gender

All

Age

No minimum to 8 Weeks

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
number of febrile episodes during the 1st year of life	—

Secondary

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

Measure

Time frame

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

—

Countries

Austria, Germany, Italy, Netherlands, Switzerland

Contacts

Public ContactGünther Boehm

Danone Research (former NUMICO Germany)

guenther.boehm@danone.com+49-6172-991320

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026