German Infant Study on the influence of Nutrition Intervention

Overview
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This resource describes a sub-study (GINI study) as the interventional part of the GINIplus study. Please visit the main resource via the associated resource ID (https://csh.nfdi4health.de/mdr/studyhub_resources/147).

SEEK ID: https://ldh-dzkj.vm.gwdguser.de/projects/6

Public web page: Not specified

Organisms: No Organisms specified

DZKJ, Standort Göttingen PALs: No PALs for this Project

Project created: 13th Jul 2026

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-184

Resource classification(*)

Type of the resource : Substudy

Title(s)/name(s) of the Project

Title/name : German Infant Study on the influence of Nutrition Intervention
Language of the title/name : English

Acronym(s) of the Project

Acronym : GINI
Language of the acronym : English

Description(s) of the Project

Description : This resource describes a sub-study (GINI study) as the interventional part of the GINIplus study. Please visit the main resource via the associated resource ID (https://csh.nfdi4health.de/mdr/studyhub_resources/147).
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Allergy and Immunology

Keyword(*) : Atopy

Keyword(*) : Diet, Food and Nutrition

Keyword(*) : Feeding Behavior

Keyword(*) : Infant Health

Keyword(*) : Child

Keyword(*) : Adolescent

Language(s) of the project : German

Web page of the project : https://www.helmholtz-munich.de/en/epi/cohort/giniplus

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Data manager
Given name(*) : Elke
Family name(s)(*) : Link
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : elke.link@iuf-duesseldorf.de
Phone number : +49 211 3389-286
Organisation(s) associated with the contributor
Name(*) : Umweltepidemiologie von Lunge, Gehirn und Hautalterung IUF – Leibniz-Institut für umweltmedizinische Forschung
Address : Auf’m Hennekamp 50 40225 Düsseldorf
Web page : https://iuf-duesseldorf.de/ag-schikowski/
Digital identifier(s)
Identifier(*) : 0163xqp73
Scheme(*) : ROR

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Marie
Family name(s)(*) : Standl
Digital identifier(s)
Identifier(*) : 0000-0002-5345-2049
Scheme(*) : ORCID
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : marie.standl@helmholtz-munich.de
Phone number : +49 89 3187 2952
Organisation(s) associated with the contributor
Name(*) : Helmholtz Zentrum München, Institute of Epidemiology
Address : Ingolstädter Landstraße 1, D-85764 Neuherberg
Web page : https://www.helmholtz-munich.de/en/epi
Digital identifier(s)
Identifier(*) : 00cfam450
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Contact
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Contact person
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : gini@helmholtz-muenchen.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Helmholtz Zentrum München, Institute of Epidemiology
Address : Ingolstädter Landstraße 1, D-85764 Neuherberg
Web page : https://www.helmholtz-munich.de/en/epi
Digital identifier(s)
Identifier(*) : 00cfam450
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : Not specified
Identifier(*) : Not specified

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Allergic disorder
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/781474001
Primary health condition or disease name(*) : Atopic dermatitis
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/24079001
Primary health condition or disease name(*) : Asthma
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/195967001
Primary health condition or disease name(*) : Allergic rhinitis
Terminology/classification(*) : SNOMED CT
Code of the health condition or disease : http://snomed.info/id/61582004
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Unknown
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (III): Recruitment completed, but data collection ongoing
Participants enrolled by invitation? : Not specified
Start date : 9 January 1995
End date : Not specified
Mono- or multicentric? : Multicentric
Number of centers : 2
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : Not specified
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Years
Eligible gender : Male, Female, Diverse
Inclusion criteria : Healthy and mature newborns with a birth weight of more than 2,500 g
Exclusion criteria : Newborns whose mothers suffered from an immunologically relevant chronic disease, like diabetes, HIV, or autoimmune disease, or who were drug or alcohol addicted, were excluded. Children whose parents were not sufficiently capable of the German language were also not included in the study. Furthermore, newborns were excluded if their families lived more than 50 km from the city center or planned to move away from the study region.
Population of the Project(*)
Coverage : Not specified
Country(ies) : Germany
Region(s) and/or city(ies) : Munich, Wesel
Interventions of the Project
Name of the intervention(*) : Formula feeding
Type of the intervention : Other
Additional information about the intervention : Newborns at high risk of allergy (defined as having at least one parent or biologic sibling with a history of allergic disease) were randomly allocated at birth to one of four blinded study formulas (partial whey hydrolyzate, extensive whey hydrolyzate or extensive casein hydrolyzate compared to standard cow's milk formula). These formulas were used during the first four months of life as a milk substitute only if exclusive breastfeeding was not possible.
Name(s) of the arm(s) associated with the given intervention : Active comparator
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Not specified
Type of the outcome measure : Not specified
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Due to data protection reasons, the datasets generated and/or analyzed within the GINI study cannot be made publicly available. The release of the data to interested researchers has to be consistent with the consent given by the GINI study participants. Ethical approval might be obtained for the release and a data transfer agreement from the legal department of the Helmholtz Zentrum München must be accepted.
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not applicable
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Care provider, Investigator, Outcomes assessor
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : No

German Infant Study on the influence of Nutrition Intervention

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