Interim status of the clinical study "Growth and Tolerance" by Jennewein Biotechnologie

25-Nov-2019 - Germany

Jennewein Biotechnologie GmbH, the leading manufacturer of human milk oligosaccharides, initiated its first clinical study in July 2018. The so-called "Growth and Tolerance" study will show that the supplementation of infant food with human milk oligosaccharides (HMOs) is very suitable for children. To assess this, a total of 324 babies are included in the study. One third each receive the food to be tested, the same preparation without the addition of HMOs, and in the third group the children are breastfed over the test period of four months. The last group represents the "gold standard" of infant nutrition. The investigational product, which is based on an infant formula commercially available in Germany and mainly contains organic quality ingredients, contains the five HMOs most commonly found in breast milk.

In contrast to the already commercial infant formula with HMOs, which contains a maximum of two neutral HMOs, the HMOs in the new preparation cover both the group of neutral and acid HMOs. A total of about 150 structurally different HMOs are known and different positive properties have been demonstrated for them. With this extended variation of HMOs in baby food, the spectrum of positive properties can also be extended. Another novelty of the food to be tested is that the concentration of HMOs used here has been adjusted to that of breast milk. To demonstrate the tolerability of ingredients in such a study is a prerequisite for their approval as food additives ("Novel Food") in accordance with EU directives. In a second aspect, the study will investigate how HMOs affect the development of the intestinal microbiome and whether there is a link between HMOs in breast milk and the intestinal microbiome of children. For this purpose, stool samples and milk samples from the mothers in the breastfeeding group are analysed by the volunteers. This clinical study is carried out with infants in Spain, Italy and Germany.

Representatives of Jennewein Biotechnologie met with the clinical doctors involved in the study at an Investigator Meeting in Frankfurt. Dr. Katja Parschat, Deputy Head of R&D and responsible for the study at Jennewein Biotechnologie, emphasised in her introduction that the primary objective was to guarantee the safety of this new product for infants by means of the results obtained. Professor Clemens Kunz from the Institute of Nutrition Science at the University of Giessen, who was invited as a guest speaker, explained the structures, functions and health effects of these complex sugar molecules in his lecture "The health benefits of human milk oligosaccharides". As an example, he cited the strengthening of the immune system and protection against allergies and infections in newborns.

The status of the recruitment of the infants involved, which started in December 2018, was subsequently presented by the participating study physicians. It has already been possible to include 2/3 of the babies fed with Formula; the group of breastfed children is even complete. Recruitment should be completed by the end of the year so that evaluation can begin. This means that recruitment has been very successful in the three countries, thanks not least to the commitment of the doctors, who can educate parents about the benefits of HMOs and thus dispel their concerns about the new products. Doctors usually address mothers who cannot or do not want to breastfeed their children.

https://www.yumda.com/en/news/1163849/interim-status-of-the-clinical-study-growth-and-tolerance-by-jennewein-biotechnologie.html