In 2001 BioGaia AB launched a clinical study with the aim to determine whether dietary supplementation of the infants with BioGaia´s health promoting bacteria Reuteri would modify the intestinal microflora and, through this, affect the incidence of allergy in early childhood. The study was done in collaboration with the Centre for Allergy Research at the Karolinska Institutet and included 232 newborn infants at four paediatric allergy clinics in Sweden
The first phase of the study is now complete, in that all the participating children have been studied up to two years of age. The babies that were supplemented with Reuteri showed significantly higher levels of the live bacteria in their gastrointestinal tracts, as compared to placebo-supplemented babies. The incidence of eczema , which is the main clinical manifestations of allergy in the first 2 years of life was, however, not significantly affected by supplementation with Reuteri.
Babies in their second year of life who were supplemented with Reuteri show a tendency towards reduced wheezing. This may be indicative of a reduced incidence of asthma later in life. Similar tendencies were observed in less rhinoconjunctivitis (hay fever) and reduced sensitization to allergens in the Reuteri-supplemented babies. As asthma and hay fever are uncommon early in life, any differences in disease prevalence are expected to become more apparent after 2 years of age. The investigators and BioGaia are therefore considering extending the study to follow up the children at the age of 5-7 years.
To be prudent BioGaia has decided to write off all capitalised development expenditures related to allergy, 10,8 million SEK, and reverse provisions for future commitments to pay royalties on future sales of allergy products with 4,9 million SEK. The result will be negatively affected by 5,9 million SEK in the last quarter 2005. The write off will not affect cash-flow.
It is of course a disappointment that the study did not show the results we expected, but we have earlier in this study seen positive effects of Reuteri supplementation on certain immune factors in mother's breast milk. We are optimistic that a possible follow up of the study at a later stage will show reduced incidences of asthma and hay fever, says Peter Rothschild, Managing Director, BioGaia.