Siri Roßberg1, Theresa Keller2, Katja Icke2, Valentina Siedmann3, Imke Lau4, Thomas Keil2,5,6, Susanne Lau1. 1. Pediatric Pulmonology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany. 2. Institute of Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany. 3. Helios Kliniken Berlin-Buch. Kinderklinik, Berlin, Germany. 4. Sektion Humanmedizin, Universität zu Lübeck, Lübeck, Germany. 5. Klinische Epidemiologie und Biometrie, Universität Würzburg, Würzburg, Germany. 6. Landesinstitut für Gesundheit, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Bad Kissingen, Germany.
Abstract
BACKGROUND: The allergy preventive effects of gut immune modulation by bacterial compounds are still not fully understood. OBJECTIVE: We sought to evaluate the effect of bacterial lysate applied orally from the second until seventh months of life on the prevalence of allergic diseases at school age. METHODS: In a randomized, placebo-controlled trial, 606 newborns with at least one allergic parent receivedorally a bacterial lysate consisting of heat-killed Gram-negative Escherichia coli Symbio and Gram-positive Enterococcus faecalis Symbio or placebo from week 5 until the end of month 7. A total of 402 children were followed until school age (6-11 years) for the assessment of current atopic dermatitis (AD), allergic rhinitis (AR), asthma and sensitization against aeroallergens. RESULTS: AD was diagnosed in 11.0% (22/200) of children in the active and in 10.4% (21/202) of children in the placebo group. AR was diagnosed in 35% (70/200) of children in the active and in 38.1% (77/202) children in the placebo group. Asthma was diagnosed in 9% (18/199) of children in the active and in 6.6% (13/197) of children in the placebo group. Sensitization occurred in 46.5% (66/142) of participants in the active and 51.7% (76/147) in the placebo group. CONCLUSION: An oral bacterial lysate of heat-killed Gram-negative Escherichia coli and Gram-positive Enterococcus faecalis applied during the first 7 months of life did not influence the development of AD, asthma and AR at school age.
RCT Entities:
BACKGROUND: The allergy preventive effects of gut immune modulation by bacterial compounds are still not fully understood. OBJECTIVE: We sought to evaluate the effect of bacterial lysate applied orally from the second until seventh months of life on the prevalence of allergic diseases at school age. METHODS: In a randomized, placebo-controlled trial, 606 newborns with at least one allergic parent received orally a bacterial lysate consisting of heat-killed Gram-negative Escherichia coli Symbio and Gram-positive Enterococcus faecalis Symbio or placebo from week 5 until the end of month 7. A total of 402 children were followed until school age (6-11 years) for the assessment of current atopic dermatitis (AD), allergic rhinitis (AR), asthma and sensitization against aeroallergens. RESULTS:AD was diagnosed in 11.0% (22/200) of children in the active and in 10.4% (21/202) of children in the placebo group. AR was diagnosed in 35% (70/200) of children in the active and in 38.1% (77/202) children in the placebo group. Asthma was diagnosed in 9% (18/199) of children in the active and in 6.6% (13/197) of children in the placebo group. Sensitization occurred in 46.5% (66/142) of participants in the active and 51.7% (76/147) in the placebo group. CONCLUSION: An oral bacterial lysate of heat-killed Gram-negative Escherichia coli and Gram-positive Enterococcus faecalis applied during the first 7 months of life did not influence the development of AD, asthma and AR at school age.