GINIplus

German Infant Study on the influence of Nutrition Intervention PLUS environmental and genetic influences on allergy development

Our website for the participants of the GINIplus study: www.ginistudie.de (in German).


Study objectives:

  • To describe the natural course of a broad spectrum of selected health parameters starting from infancy to young adulthood with focusing on the development of atopic diseases.
  • To determine the impact of feeding regimen in infancy, environmental exposures, life style factors and genetic predisposition.
  • To investigate the influence of mental health, nutrition, body weight and physical activity on the health of children.


Specific aims:

  • What is the natural course of atopic diseases, growth and obesity-related health disorders in German children?
  • Is there a long-term effect of hypo allergen formula fed in infancy on preventing the development of atopic diseases?
  • What is the quantitative influence of exposure to air pollution and allergens on the development of atopic diseases and respiratory health?
  • Description of genetic influences on asthma, atopic dermatitis: Is there modification of effects of allergens and traffic related particulate matter by genetic predisposition?
  • What are other comorbidities of atopic diseases?
  • What are the major life-style determinants of atopic diseases, growth, obesity, and other health problems?


Study design:

GINIplus is a multicentre, population-based prospective birth cohort study. The study consists of two arms: an interventional and an observational arm. Both arms together represent a population-based birth cohort. Newborns with family history of allergy were recruited for the interventional arm (GINI = German Infant Nutritional Intervention program): a randomized, double-blind controlled trial with 3 hydrolysed formula versus cow’s milk formula feeding during first 4 months of life (n=1165 in Munich, n=1087 in Wesel). Newborns with a negative family history or positive family history but refusing participation at the trial were included to the observational study arm.
 For the ongoing 20-year-follow up more than 3000 children will be followed.

Study population:
Healthy, term newborns with and without family history of allergy were recruited for the study (n=2949 in Munich, n=3042 in Wesel).

Study area:
Prospective birth cohort study in two regions in Germany : Munich (urban, South-East), Wesel (rural, North-West).

Study methods:

Interventional arm (0-3 years):

  • personal interviews and physical examination at age 1, 4, 8, 12 , 24 and 36 months
  • telephone-interview at age 18 months
  • blood analyses: cord blood IgE at birth and total/specific IgE at age 4, 12, 36 months.


Observational arm together with the interventional arm (ongoing):

  • self-administered questionnaires for parents at children’s age 1, 2, 3, 4, 6, 10 and 15 years
  • self-administered questionnaires for children at age 10, 15 and 20 years
  • blood sampling: cord blood IgE at birth and total/specific IgE at age 6, 10 and 15 years, measurement of inflammatory and metabolic biomarkers in blood
  • urine analyses at age of 15 years
  • physical activity monitoring based on accelerometry at age 15 and 20 years
  • examination modules at age of 15 years:
    • anthropometry, body composition (BIA)
    • blood pressure
    • physical examination of the skin
    • lung function testing (spirometry)
    • hand grip test
    • food frequency questionnaire

Study period:
Recruitment period: 09/1995-06/1998, follow-up since birth.

Current status:
The 20-year-follow up has started at the beginning of 2016.

Main Investigators:

Study region Munich:

Helmholtz Zentrum München - Institute of Epidemiology: Marie Standl (PI GINIplus)

Kinderklinik und Kinderpoliklinik, Dr. v. Haunersches Kinderspital, University of Munich: Sibylle Koletzko (PI GINIplus)
Kinderklinik und Poliklinik, Technische Universität München: Carl P. Bauer (PI GINIplus).

Wesel:
Marien-Hospital Wesel, Department of Pediatrics: Dietrich Berdel (PI GINIplus), Andrea von Berg.

Düsseldorf:
Institut für Umweltmedizinische Forschung (IUF) Düsseldorf: Tamara Schikowski (PI GINIplus).


Funding:

Federal Ministry of Education and Research, Germany (BMBF)
Helmholtz Zentrum München - Institute of Epidemiology, Germany.

Contact:
Dr. Marie Standl
Ingolstädter Landstraße 1
D-85764 Neuherberg
Tel. +49-(0)89-3187-2952
Fax +49-(0)89-3187-3380


Related publications:

Markevych I, Baumbach C, Standl M, Koletzko S, Lehmann I, Bauer CP, Hoffmann B, von Berg A, Berdel D, Heinrich J:
Early life travelling does not increase risk of atopic outcomes until 15 years: results from GINIplus and LISAplus.
Clin Exp Allergy. 2017 Mar;47(3):395-400.
Abstract

Fuertes E, Markevych I, Bowatte G, Gruzieva O, Gehring U, Becker A, Berdel D, von Berg A, Bergström A, Brauer M, Brunekreef B, Brüske I, Carlsten C, Chan-Yeung M, Dharmage SC, Hoffmann B, Klümper C, Koppelman GH, Kozyrskyj A, Korek M, Kull I, Lodge C, Lowe A, MacIntyre E, Pershagen G, Standl M, Sugiri D, Wijga A, Heinrich J.
Residential greenness is differentially associated with childhood allergic rhinitis and aeroallergen sensitization in seven birth cohorts.
Allergy. 2016 Oct;71(10):1461-71.
Abstract

Smith MP, von Berg A, Berdel D, Bauer CP, Hoffmann B, Koletzko S, Nowak D, Heinrich J, Schulz H.
Physical activity is not associated with spirometric indices in lung-healthy German youth.
Eur Respir J. 2016 Aug;48(2):428-40.
Abstract

von Berg A, Filipiak-Pittroff B, Schulz H, Hoffmann U, Link E, Sußmann M, Schnappinger M, Brüske I, Standl M, Krämer U, Hoffmann B, Heinrich J, Bauer CP, Koletzko S, Berdel D; GINIplus study group.
Allergic manifestation 15 years after early intervention with hydrolyzed formulas--the GINI Study.
Allergy. 2016 Feb;71(2):210-9.
Abstract

Rzehak P, Wijga AH, Keil T, Eller E, Bindslev-Jensen C, Smit HA, Weyler J, Dom S, Sunyer J, Mendez M, Torrent M, Vall O, Bauer CP, Berdel D, Schaaf B, Chen CM, Bergström A, Fantini MP, Mommers M, Wahn U, Lau S, Heinrich J; GA²LEN-WP 1.5 Birth Cohorts.
Body mass index trajectory classes and incident asthma in childhood: results from 8 European Birth Cohorts--a Global Allergy and Asthma European Network initiative.
J Allergy Clin Immunol. 2013 Jun;131(6):1528-36.
Abstract

von Berg A, Filipiak-Pittroff B, Krämer U, Hoffmann B, Link E, Beckmann C, Hoffmann U, Reinhardt D, Grübl A, Heinrich J, Wichmann HE, Bauer CP, Koletzko S, Berdel D; GINIplus study group.
Allergies in high-risk schoolchildren after early intervention with cow's milk protein hydrolysates: 10-year results from the German Infant Nutritional Intervention (GINI) study.
J Allergy Clin Immunol. 2013 Jun;131(6):1565-73.
Abstract

Rzehak P, Sausenthaler S, Koletzko S, Reinhardt D, von Berg A, Krämer U, Berdel D, Bollrath C, Grübl A, Bauer CP, Wichmann HE, Heinrich J; GINI-plus Study Group.
Long-term effects of hydrolyzed protein infant formulas on growth--extended follow-up to 10 y of age: results from the German Infant Nutritional Intervention (GINI) study.
Am J Clin Nutr. 2011 Dec;94(6 Suppl):1803S-1807S.
Abstract

Cramer C, Link E, Horster M, Koletzko S, Bauer CP, Berdel D, von Berg A, Lehmann I, Herbarth O, Borte M, Schaaf B, Behrendt H, Chen CM, Sausenthaler S, Illig T, Wichmann HE, Heinrich J, Krämer U; LISAplus Study Group and the GINIplus Study Group: Elder siblings enhance the effect of filaggrin mutations on childhood eczema: results from the 2 birth cohort studies LISAplus and GINIplus.
J Allergy Clin Immunol. 2010 Jun;125(6):1254-1260.
Abstract

von Berg A, Krämer U, Link E, Bollrath C, Heinrich J, Brockow I, Koletzko S, Grübl A, Filipiak-Pittroff B, Wichmann HE, Bauer CP, Reinhardt D, Berdel D; GINIplus study group.
Impact of early feeding on childhood eczema: development after nutritional intervention compared with the natural course - the GINIplus study up to the age of 6 years.
Clin Exp Allergy. 2010 Apr;40(4):627-36.
Abstract

Schmitt J, Apfelbacher C, Chen CM, Romanos M, Sausenthaler S, Koletzko S, Bauer CP, Hoffmann U, Krämer U, Berdel D, von Berg A, Wichmann HE, Heinrich J; German Infant Nutrition Intervention plus Study Group:
Infant-onset eczema in relation to mental health problems at age 10 years: results from a prospective birth cohort study (German Infant Nutrition Intervention plus).
J Allergy Clin Immunol. 2010 Feb;125(2):404-10.
Abstract

Rzehak P, Sausenthaler S, Koletzko S, Reinhardt D, von Berg A, Krämer U, Berdel D, Bollrath C, Grübl A, Bauer CP, Wichmann HE, Heinrich J; German Infant Nutritional Intervention Study Group:
Short- and long-term effects of feeding hydrolyzed protein infant formulas on growth at < or = 6 y of age: results from the German Infant Nutritional Intervention Study.
Am J Clin Nutr. 2009 Jun;89(6):1846-56.
Abstract

von Berg A, Filipiak-Pittroff B, Krämer U, Link E, Bollrath C, Brockow I, Koletzko S, Grübl A, Heinrich J, Wichmann HE, Bauer CP, Reinhardt D, Berdel D; GINIplus study group:
Preventive effect of hydrolyzed infant formulas persists until age 6 years: long-term results from the German Infant Nutritional Intervention Study (GINI).
J Allergy Clin Immunol. 2008 Jun;121(6):1442-7.
Abstract

Filipiak B, Zutavern A, Koletzko S, von Berg A, Brockow I, Grübl A, Berdel D, Reinhardt D, Bauer CP, Wichmann HE, Heinrich J.:
Solid Food Introduction in Relation to Eczema: Results from a Four-Year Prospective Birth Cohort Study.
Allergo J 2008; 17:82-83.
Abstract

Chen CM, Morgenstern V, Bischof W, Herbarth O, Borte M, Behrendt H, Krämer U, von Berg A, Berdel D, Bauer CP, Koletzko S, Wichmann HE, Heinrich J; Influences of Lifestyle Related Factors on the Human Immune System and Development of Allergies in Children (LISA) Study Group; German Infant Nutrition Intervention Programme (GINI) Study Group.
Dog Ownership and Contact during Childhood and Later Allergy Development.
Eur Respir J 2008 May;31(5):963-73.
Abstract

von Berg A, Koletzko S, Filipiak-Pittroff B, Laubereau B, Grubl A, Wichmann HE, Bauer CP, Reinhardt D, Berdel D; for the German Infant Nutritional Intervention Study Group:
Certain hydrolyzed formulas reduce the incidence of atopic dermatitis but not that of asthma: Three-year results of the German Infant Nutritional Intervention Study.
J Allergy Clin Immunol. 2007; 119(3):718-25.
Abstract

Laubereau B, Brockow I, Zirngibl A, Koletzko S, Grübl A, von Berg A, Filipiak-Pittroff B, Berdel D, Bauer CP, Reinhardt D, Heinrich J, Wichmann HE, for the GINI Study Group:
Effects of Breastfeeding on the development of atopic dermatitis during the first 3 years of life-Results from the GINI-birth cohort study.
The Journal of Pediatrics 2004; 602-606.
Abstract

Gehring U, Cyrys J, Sedlmeir G, Brunekreef B, Bellander T, Fischer P, Bauer CP, Reinhardt D, Wichmann HE, Heinrich J:
Traffic-related air pollution and respiratory health during the first 2 yrs of life.
Eur Respir J 2002; 19:690-698.
Abstract

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