GINI PLUS:
German Infant Study on the influence of Nutrition Intervention PLUS environmental and genetic influences on allergy development
Study objectives:
- To describe child health in Germany focusing on the development of atopic diseases
- To determine the impact of feeding regimen in infancy, environmental exposures and genetic predisposition.
Specific aims:
- What is the natural course of atopic diseases in German children?
- Is there a long-term effect of hypoallergen formula fed in infancy on preventing the development of atopic diseases?
- What is the quantitative influence of air pollution and allergens indoor and outdoor on the development of atopic diseases (focusing on interaction polluting agents- allergens)?
- Description of genetic influences on asthma, atopic dermatitis: Is there modification of effects of allergens and traffic related PMs by genetic predisposition?
Study design:
Children with family history of allergy were recruited for an interventional study (GINI = German Infant Nutritional Intervention program): a randomized, controlled trial with 3 hydrolysed formula versus cow’s milk formula during first 4 months of life (n=1165 in Munich, n=1087 in Wesel).
For the 6-year follow-up about 4000 children will be contacted.
Study population:
Healthy, term newborns with and without family history of allergy were recruited for the observational 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 part ( 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 part (ongoing):
- yearly self-administered questionnaires for parents at children’s age 1, 2, 3, 4, 6, and 10 years
- blood analyses: cord blood IgE at birth and total/specific IgE at age 6 and 10 years, measurement of inflammatory and metabolic biomarkers in blood.
Subgroups:- physical examination of the skin, skin prick test
- lung function testing (spirometry)
- taste sensitivity testing at age of 10 years
Study period:
Recruitment period: 09/1995-06/1998, follow-up since birth
Current status:
The 10 year- follow-up was finished.
Investigators:
Study region Munich:
Helmholtz Zentrum München - Institute of Epidemiology: Joachim Heinrich (GINI PLUS), H.-Erich Wichmann
Kinderklinik und Kinderpoliklinik, Dr. v. Haunersches Kinderspital, University of Munich: Sibylle Koletzko, Dietrich Reinhardt (PI GINI)
Kinderklinik und Poliklinik, Technische Universität München: Carl P. Bauer (PI GINI), Armin Grübl, Uta Hoffmann
Wesel:
Marien-Hospital Wesel, Department of Pediatrics: Dietrich Berdel (PI GINI), Andrea von Berg, Christina Bollrath
Düsseldorf:
Institut für Umweltmedizinische Forschung (IUF) Düsseldorf: Ursula Krämer (PI GINI PLUS), Ulrich Ranft, Elke Link
Collaboration:
Zentrum Allergie und Umwelt München (ZAUM): Heidrun Behrendt, Anna Kasche
Institut für Energie und Umwelttechnik (IUTA): Thomas Kuhlbusch
Klinik und Poliklinik für Dermatologie und Allergologie – am Biederstein – der Technischen Universität München: Johannes Ring
Funding:
Federal Ministry of Education and Research Germany (BMBF)
Helmholtz Zentrum München - Institute of Epidemiology, Germany
Institut für Umweltmedizinische Forschung (IUF) Düsseldorf, Germany
Contact:
Helmholtz Zentrum München
Institute of Epidemiology
Dr. Joachim Heinrich
P.O. Box 1129
D-85758 Neuherberg
Tel. +49-(0)89-3187-4150
Fax +49-(0)89-3187-3380
joachim.heinrich@helmholtz-muenchen.de
Related publications:
von Berg A, S Koletzko, B Filipiak-Pittroff, B Laubereau, A Grubl, HE Wichmann, CP Bauer, D Reinhardt, D Berdel; 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
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.
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
Chen CM, Gehring U, Wickman M, Hoek G, Giovannangelo M, Nordling E, Wijga A, de Jongste J, Pershagen G, Almqvist C, Kerkhof M, Bellander T, Wichmann HE, Brunekreef B, Heinrich J.
Domestic Cat Allergen and Allergic Sensitisation in Young Children.
Int J Hyg Environ Health 2008, 211:337-344.
Abstract
Laubereau B, I Brockow, A Zirngibl, S Koletzko, A Grübl, A von Berg, B Filipiak-Pittroff, D Berdel, CP Bauer, D Reinhardt, J Heinrich, H-E Wichmann, 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
Laubereau B, B Filipiak-Pittroff, A von Berg, A Grübl, D Reinhardt, H-E Wichmann, S Koletzko for the GINI Study Group:
Caesarean section and gastrointestinal symptoms, atopic dermatitis and sensititzation during the first year of life.
Arch Dis Child. 2004 Nov; 89(11):993-7.
Abstract
von Berg A, S Koletzko, A Grübl, B Filipiak-Pittroff, H-E Wichmann, CP Bauer, D Reinhardt, D Berdel, for the GINI Study Group:
The effects of hydrolyzed cow’s milk formula for allergy prevention in the first year of life: The German Infant Nutritional Intervention Study, a randomized double-blind trial.
J Allergy Clin Immunol 2003; 111:533-540.
Abstract
Gehring U, J Cyrys, G Sedlmeir, B Brunekreef, T Bellander, P Fischer, CP Bauer, D Reinhardt, HE Wichmann, J Heinrich:
Traffic-related air pollution and respiratory health during the first 2 yrs of life.
Eur Respir J 2002; 19:690-698.
Abstract