NEOCOL 2017-2022
The NEOCOL project develops Danish special produced bovine colostrum as diet supplement for preterm infants the first weeks after birth. Mother’s own milk is the preferred diet for preterm infants, but is often unavailable, insufficient or deficient in nutrients, especially during the first weeks after preterm birth. The aim is to provide documentation for an optimal high quality, cost-effective Danish colostrum product to be used as a first feed, diet supplement or human milk fortifier. This should promote gastrointestinal health, immune defense and brain development, improve organ functions, help mature the intestinal epithelium in premature children and improve the nutritional care for preterm infants worldwide.
The colostrum product should be a better alternative to human donor milk and infant formulas, which are difficult, expensive and non-optimal diets for premature infants. Tolerance and risk assessment of the bovine colostrum powder product has recently been tested in a smaller study in children in Denmark and China.
During NEOCOL, studies on the health effects of colostrum in preterm infants will be conducted in two major studies in Denmark and China, parallel with further studies on the health effects in preterm piglets used as models for preterm infants. In addition, the production of bovine colostrum powder is further optimized. Together, these studies should support the use of a new colostrum quality product to supplement nutrition with breast milk the first weeks after preterm childbirth.
NEOCOL is the subsequent study to NEOMUNE and is building on the study results from here. Results from NEOMUNE highlighted bovine colostrum as a superior diet supplement to mothers own milk in preterm piglets representing preterm infants with very low gestational age and/or very low birth weight in relation to infant formula and partly in relation to human donor milk. The studies focused on suppression of dysfunctions and diseases, improvement of the state of the gut and immune system, and enhancement of the general health status. Bovine colostrum was also proved to be feasible as diet supplement for preterm infants in clinical pilot trials.
Every year 15 million babies are born preterm that is at less than 37 weeks gestational age. Of these, some are born very preterm (≤ 33 weeks) and/or with a very low birth weight (≤ 1500g). For preterm infants, the gastrointestinal and immune systems are not fully developed and they may potentially suffer from severe diseases and/or functional complications. The degree is decreasing with gestational age and birth weight. Preterm infants with very low gestational age and birth weight are thus in critically need of optimal care.
Mother’s milk is the optimal diet for infants, but is often in limited supply related to preterm births as the production of milk is timed to match normal birth time. Several studies report that preterm infants with a very low gestational age and/or very low birth weight need a new fortified product as a replacement for the traditional infant formula or as a fortifier for pasteurized human donor milk. The latter having a lower content of bioactive ingredients compared to colostrum, as it is from later in lactation and have been processes. As such, the world face needs of a new diet supplement to stimulate body growth and development of gastrointestinal and immune system in neonatal infants.
The development of the bovine colostrum powder product in NEOCOL is based on results obtained during the last 10 years using premature piglets, a recognized animal model for premature infants. The model was developed in Denmark under the leadership of Professor Per Sangild, who also leads the NEOMUNE Centre and the NEOCOL project.
Work packages in NEOCOL
Biofiber Damino A/S is an industrial partner in NEOMUNE and provides bovine colostrum for the research in:
Work Package 1 – Optimizing the processing conditions of colostrum to be used for hospitalized infants
Work Package 2 – Verification of the mechanisms of colostrum actions in immature get cells and against pathogens
Work Package 3 – Documentation of gut, immunity and brain effects of colostrum in preterm pigs, used as a model for infants
Work Package 4 – Verification of safety and efficacy of colostrum used as first feed or human milk fortifier for preterm infants
Work Package 5 – Application of state-of-the-art lab analyses of milk, cell, pig and infant samples to document colostrum effects
NEOCOL is financially supported by the Innovation Fund Denmark, read more about NEOCOL on their web site.
Partners
Department of Veterinary and Animal Sciences, University of Copenhagen
Department of Food Science, University of Copenhagen
Biofiber-Damino A/S
Department of Pediatrics, Odense University Hospital
Center for Advanced Pediatric Nutrition and the Neonatology Department, Rigshospitalet
Collaborators
Centre for Neonatal Research and Education, University of Western Australia and King Edward Hospital for Women, Perth, Australia
School of Public Health, Sun-Yat Sen University, Guangzhou, China
Steering Committee
Vice-Dean Erik B. Madsen, University of Copenhagen
Dept. Head Birgit Nørrung, University of Copenhagen
Director Gunner Jacobsen, Biofiber-Damino A/S
Professor Arne Høst, Odense University Hospital
Professor Gorm Greisen, Rigshospitalet
Biofiber Damino A/S provide bovine colostrum for the research in NEOCOL.
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NEOMUNE 2013-2017
NEOMUNE is a research project that aims to improve clinical care of newborn infants, particular those born with developmental problems. The focus is on the effect of the first enteral uptake and the development of microbiota in the intestine and analyze of the possible effects on the development of the brain. The focus is also to clarify the effects on an optimal maturation of the intestine, both in relation the necrotizing enterocolitis and to create a better understanding of the complexity of preterm infants’ needs.
Right after birth, all newborns have to adapt to new food, feeding method and colonization of billions of bacteria in the gastrointestinal tract. The colonization counts the same number of bacteria whatever the feeding method, but the bacteria types found in the gut depends on the composition and dose regime of the feeding method used. These factors in digestive development is essentially for all newborn babies, but is even more crucial for preterm infants, especially those born at low gestational age and with a very low birth weight. Caesarean birth, high hygiene levels, antibiotics treatments and impropriate formula feeding may disturb the immune system maturation resulting in reduced growth, infections and impaired growth of key organs like brain, heart and gut. Such problems are often severe in preterm infants and babies with low birth weight. Much are still unknown about the consequences of such problems on the development of the infants.
Denmark is a pioneer in using pigs as animal model for humans. In NEOMUNE, studies on preterm piglets are used as models for preterm infants; to show how infections, digestion and brain function is affected by different bacteria, microflora, and the milk during the first few weeks of life. The model studies are linked to studies on preterm infants once the relevant factors has been identified.
NEOMUNE have analyzed several possibilities for optimizing diet supplements for preterm infants and found bovine colostrum as the most potential supplement and fortifier. Based on these results, the University of Copenhagen created a group of partners to go further along this way (see NEOCOL). During the time of NEOMUNE several publications on the use of bovine colostrum has been published in different peer-reviewed journals and magazines. The main observance is a remarkably good effect on preterm piglets fed bovine colostrum. Their mortality and illness decrease markedly, compared with preterm piglets fed on donor human milk or infant formula. Also, bovine colostrum was proved to be feasible as diet supplement for preterm infants in a clinical pilot study. Based on these observations, the same colostrum matrix is used in NEOCOL.
NEOMUNE creates an international research platform with focus on the health, development and diseases of preterm infants. The center is located on the Copenhagen University, Denmark, and consist of scientist from all over the world, infant hospitals and industrial partners. This creates a close relation and interaction between the relevant partners and secures the usefulness of the research in the work against diseases in preterm infants.
Work packages in NEOMUNE
Biofiber Damino A/S is an industrial partner in NEOMUNE and provides bovine colostrum for the research in:
Work Package 1 - Infants
WP 1.2 Infection rates and associations with birth method, breast-feeding and antibiotics
WP 1.6 Early enteral feeding to support health
Work Package 2 - Piglets studies for proof of concept
WP 2.3 Enteral feeding and its improvements on immunity and organ maturation
Read more about NEOMUNE on www.neomune.ku.dk.
NEOMUNE is financially supported by the Innovation Fund Denmark, read more about NEOMUNE on their website.
Partners
Copenhagen University, Denmark
Rigshospitalet, Denmark
Odense University Hospital, Denmark
Biofiber Damino A/S, Denmark
Arla Foods amba, Denmark
University of Amsterdam, Netherlands
Schenzhen Maternity and Child Health Hospital, China
University of Glessen, Deutschland
DTU, Denmark
Aarhus University, Denmark
Chr. Hansen A/S, Denmark
Fresenius Kabi, Denmark
Mead Johnson, USA
Danone, Denmark
Governing Board
Jacob Holm Nielsen (AFI)
Arne Høst (OUH)
Erik Bisgaard Madsen (SCIENCE-UCPH)
Biofiber Damino A/S supported the project by providing bovine colostrum for the research.
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Bovine colostrum for gut protection and recovery 2008-2012
Project title: Gastrointestinal toxicity and inflammatory responses during treatment of childhood acute lymphoblastic leukemia.
This PhD-project aimed to investigate the potential of bovine colostrum as an alternative to sow’s milk to preterm piglets suffering from formula-induced necrotizing enterocolitis. The project was later included in the NEOMUNE research portfolio.
Clinical Trials: NCT01766804
Partners
H. C. Andersens Children's Hospital, Odense University Hospital, Denmark
Institute of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Denmark
Clinical and Experimental Nutrition Group, Department of Human Nutrition, University of Copenhagen
Biofiber Damino A/S, Denmark
Biofiber Damino A/S supported the project by providing bovine colostrum for the research.
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Bovine colostrum for gut health in preterm pig models 2008-2012
Project title: The effect of bovine colostrum products on intestinal dysfunction and inflammation in a preterm pig model of necrotizing enterocolitis.
This PhD-project aimed to investigate the effects of bovine colostrum on the gastrointestinal health when provided as diet supplements to preterm piglets. This project is the first to investigate bovine colostrum as diet supplement for preterm infants, using preterm piglets as animal model.
Partners
National Veterinary Institute, Technical University of Denmark, Denmark
Clinical and Experimental Nutrition Group, Department of Human Nutrition, University of Copenhagen
Biofiber Damino A/S, Denmark
Biofiber Damino A/S supported the project by providing bovine colostrum for the research.
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Biodane Pharma encourages research in colostrum as clinical nutrition by supplying for trials. Contact us for more information.
Biodane Pharma A/S belongs to the BIODAN GROUP that also holds the company Biofiber Damino A/S, which develops and produce animal and human health products. Research cooperations are linked to Biodane Pharma A/S and the BIODAN GROUP through Biofiber Damino A/S.
