Observational, double-blind, controlled and randomised follow up study as an extension of a double-blind controlled study with a parallel group design on the effect of formula feeding (IF and FOF) supplemented with a mixture of immunologically active neutral and acidic oligosaccharides in healthy term born infants during their first year of life (during MIPS 1) on the incidence of atopic diseases and infections between their 3rd year of life until the completion of their 5th year of life. Amd 3: around their 3rd birthday until the completion of their 7th year of life

Observational, double-blind, controlled and randomised follow up study as an extension of a double-blind controlled study with a parallel group design on the effect of formula feeding (IF and FOF) supplemented with a mixture of immunologically active neutral and acidic oligosaccharides in healthy term born infants during their first year of life (during MIPS 1) on the incidence of atopic diseases and infections between their 3rd year of life until the completion of their 5th year of life. Amd 3: around their 3rd birthday until the completion of their 7th year of life - MIPS Follow-Up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00000229

Enrollment

667

Registered

2009-10-08

Start date

2008-11-12

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

Follow Up of MIPS children regarding infections and atopic diseases B99 L20.9 J30.1 J45.0 K52.2 K58.0 K59.0

Interventions

None listed

Eligibility

Sex/Gender

All

Age

2 Years to 4 Years

Inclusion criteria

Inclusion criteria: -Participation in MIPS I -Willing to comply with the study protocol and having given written informed consent

Exclusion criteria

Exclusion criteria: -Planned move to another area/country which leads to termination of study participation -Unwillingness of the parents/mother/study child to comply with the protocol requirements -Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Design outcomes

Primary

Measure	Time frame
Incidence of febrile episodes and episodes of atopic diseases (atopic dermatitis, hay fever, allergic asthma, food allergy) -Method: quarterly documentation in CRF based on continuous diary entries resp. quarterly completion of questionnaire (ISAAC oriented). SCORAD assessment on study inclusion and during a personal visit at each full year of life. Amd: 3: after 5th year of life half yearly questionnaire (ISAAC oriented). SCORAD at yearly personal visit, spirometry at 7 y of life.	—

Measure

Time frame

Incidence of febrile episodes and episodes of atopic diseases (atopic dermatitis, hay fever, allergic asthma, food allergy) -Method: quarterly documentation in CRF based on continuous diary entries resp. quarterly completion of questionnaire (ISAAC oriented). SCORAD assessment on study inclusion and during a personal visit at each full year of life. Amd: 3: after 5th year of life half yearly questionnaire (ISAAC oriented). SCORAD at yearly personal visit, spirometry at 7 y of life.

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Secondary

Measure	Time frame
-Symptoms of illnesses indicating a viral or bacterial infection (by diary entries) -Biochemical blood/plasma parameters of immune status, at least in a subgroup of infants (optional blood sample at age 3 and 5) -Stool parameters (stool sample at age 3, 4 and 5) and gut health (Questionnaire at age 3 and 5) -Anthropometric parameters (Measurement of length, weight, head circumference, triceps skinfold thickness, subscapular skinfold thickness, mid upper arm circumference, hip and waist circumference upon study entry and on each full year of life ) Amd 3: until the completion of 7 years) Amd 3: -biochemical blood/plasma parameters of immune status (optional blood sample at age 7) -stool parameters (stool sample at age 6 and 7) -lung funtion parameters/spirometry at age 7 -optional buccal swab (once at age 6 or 7)	—

Measure

Time frame

-Symptoms of illnesses indicating a viral or bacterial infection (by diary entries) -Biochemical blood/plasma parameters of immune status, at least in a subgroup of infants (optional blood sample at age 3 and 5) -Stool parameters (stool sample at age 3, 4 and 5) and gut health (Questionnaire at age 3 and 5) -Anthropometric parameters (Measurement of length, weight, head circumference, triceps skinfold thickness, subscapular skinfold thickness, mid upper arm circumference, hip and waist circumference upon study entry and on each full year of life ) Amd 3: until the completion of 7 years) Amd 3: -biochemical blood/plasma parameters of immune status (optional blood sample at age 7) -stool parameters (stool sample at age 6 and 7) -lung funtion parameters/spirometry at age 7 -optional buccal swab (once at age 6 or 7)

—

Countries

Austria, Germany, Italy, Netherlands, Switzerland

Contacts

Public ContactGünther Boehm

Danone Research

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

Outcome results