2017
FortiColos begins recrutiment
The clinical study FortiColos is initiated shortly after PreColos-RCT and is a corresponding project located in Denmark. The focus is to investigate the safety, tolerability and the preliminary effects of bovine colostrum used as a fortifier for mother's own milk and human donor milk in very preterm infants. This pilot trial is a multicentre, two-arm, unblended, randomized, and controlled trial. Recruitment is opened and the expected enrolment is 200 preterm infants in 6 Danish hospitals.
ClinicalTrials.gov: NCT03537365.
PreColos-RCT begins recruitment
PreColos-RCT is initiated as the first clinical trials in NEOCOL. This is the succeeding project to PreColos and is based on the results and experiences obtained from it. The focus is to test bovine colostrum versus infant formula as the first nutrient supplemental nutrition to mother's own milk for very preterm infants in a large multicentre, two-arm, unblended, randomized, and controlled trial. Recruitment is opened and the expected enrolment is 352 preterm infants in 9 Chinese hospitals.
ClinicalTrials.gov: NCT03085277.
NEOCOL begins
The project NEOCOL begins. This project is a succession of NEOMUNE and focus directly on the development of a new diet supplement for neonates, especially preterm infants, based on intact bovine colostrum powder. The aim is to develop a highly specialized product that decrease diseases and improve organ functions. Biodane Pharma A/S delivers bovine colostrum powder for the clinical trials.
NEOMUNE ends
The project NEOMUNE is completed. Massive data on the feasibility of bovine colostrum as diet supplement for preterm piglets indicate that bovine colostrum is the best option as diet supplement for mother’s own milk. Results from PreColos demonstrate that bovine colostrum is feasible as diet supplement for preterm infants, and the results obtained on preterm piglets may thus be expected to be recreated in future clinical trials on preterm infants. Bovine colostrum may thus prove to be a highly feasible and beneficial diet supplement for preterm infants. Such results may also hold the promise of use of intact bovine colostrum powder as diet supplement for several other patient groups with gastrointestinal disorders and diseases.
Read more about the results published from NEOMUNE here.
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2016
PreColos is finished
PreColos: The first clinical studies on bovine colostrum as diet supplement for preterm infants have been conducted on hospitals in Denmark and China and the results reveal high feasibility and no adverse effects. Results are published in 2017 in the papers: A stepwise, pilot study of bovine colostrum to supplement the first enteral feeding in preterm infants (PreColos): study protocol and initial results and Bovine colostrum for preterm infants in the first days of life: a randomized controlled pilot study. The first steps towards larger clinical trials are planned.
ClinicalTrials.gov: NCT02054091.
Results from NEOMUNE
More results from NEOMUNE is published, and now also report that bovine colostrum seems to be the better choice as diet supplement for preterms relative to infant formula and even human donor milk. Bovine colostrum improves neonatal growth, digestive function, and gut immunity relative to both human donor milk and infant formula in preterm piglets. These results strongly support the theory that intact bovine colostrum may be a very good diet supplement for preterm infants, and emphasise the first feasibility pilot clinical trials on preterm infants. As preterm piglets have proven to be a good animal model for preterm infants, the results obtained in NEOMUNE is expected to be recreated on preterm infants in time.
Published papers from studies using bovine colostrum provided by Biodane Pharma A/S is listed here: Research papers on colostrum.
Read more about the results from NEOMUNE here.
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2015
PreColos is started
The first clinical studies on bovine colostrum as diet supplement for preterm infants are conducted on hospitals in Denmark and China in a pilot feasibility study. Results from all seven enrolled preterm infants in the first two phases A and B in the project reveal high feasibility and no adverse effects. The results are published in A stepwise, pilot study of bovine colostrum to supplement the first enteral feeding in preterm infants (PreColos): study protocol and initial results. Based on these results, the phase C is intented in Danish and Chinese hospitals, now with 40 preterm infants.
ClinicalTrials.gov: NCT02054091.
Results from NEOMUNE
New results from NEOMUNE are published and all report beneficial effects from intake of bovine colostrum relative to especially infant formula, but also human donor milk. Bovine colostrum is reported to be feasible as enteral feeding as it minimizes severe adverse effects that usually follows enteral feeding of preterms. It is shown that gradual enteral feeding of bovine colostrum improves gut function and resistance to necrotizing enterocolitis, reduce colonization by E. coli bacteria, and lower the frequency of diarrhea. Also, the best feeding practices of preterms are investigated. The studies are performed on preterm piglets, used as animal models for preterm infants, and they strongly indicate the beneficial effects from intake of bovine colostrum by preterms.
Published papers from studies using bovine colostrum provided by Biodane Pharma A/S is listed here: Research papers on colostrum.
Read more about the results from NEOMUNE here.
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2014
First results from NEOMUNE on preterm piglets indicate high feasibility and effect
The first results from NEOMUNE are published. They report feasibility of bovine colostrum as diet supplement on preterm piglets indicate high feasibility and improvement of gut function and response. This includes the papers from the PhD on the effects from bovine colostrum on intestinal dysfunctions in preterm piglets, a review on the clinical applications of bovine colostrum and the first test between bovine colostrum and infant formula, showing that bovine colostrum improves gut response to enteral feeding relative to infant formula. These results secures the continuing research on bovine colostrum as diet supplement for preterm piglets with the future prospect of using the results to see if bovine colostrum as diet supplement for preterm infants is feasible. Based on those results actions are taken to start up a project with preterm infants.
Published papers from studies using bovine colostrum provided by Biodane Pharma A/S is listed here: Research papers on colostrum.
Read more about the results from NEOMUNE here.
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2013
NEOMUNE begins
The project NEOMUNE is started. NEOMUNE is a research project that aims to improve clinical care of neonate infants, especially those born with developmental problems. The overall objective is to develop new diet treatments for the neonate infants. The first clinical studies use preterm piglets as model animals for preterm infants, due to preterm infants being a particularly vulnerable patient group. The piglet models are based on the international recognized pig model for human gastrointestinal disorders developed partly by Per T. Sangild.
Clinical studies on bovine colostrum against chemotherapy-induced gut toxicity in children
Clinical studies on paediatric chemotherapy patients are commenced at H. C. Andersen Children’s Hospital, Odense University Hospital and on Rigshospitalet, Copenhagen, and are still ongoing. The aim is to investigate the properties of bovine colostrum diet supplementation to prevent and treat chemotherapy-induced gastrointestinal toxicity in paediatric patients receiving induction treatment for acute lymphoblastic leukaemia. The clinical research is based on the development of a doxorubicin based piglet model of chemotherapy-induced gastrointestinal toxicity utilized for testing increasing doses of bovine colostrum.
The study is registered at ClinicalTrials.gov: NCT01766804.
Paediatric chemotherapy patients constitute a particularly vulnerable patient group that are dependent on the recovery of a damaged gut and reductions of inflammation in the gastrointestinal tract is essential to their recovery. As children with chemotherapy induced gastrointestinal toxicity shows the same clinical symptoms as preterm infants, this project was included in NEOMUNE as preceding safety-studies demonstrating the expectation of feasibility of bovine colostrum as human diet supplement for preterm infants. The first results on effect of bovine colostrum on chemotherapy-induced intestinal toxivity in piglets are published in the papers Doxorubicin-induced gut toxicity in piglets fed bovine milk and colostrum and Milk diets influence doxorubicin-induced intestinal toxicity in piglets.
Biodane Pharma provides bovine colostrum powder for the clinical trials.
Biodane Pharma launches first product with intact bovine colostrum powder
Biodane Pharma receives accept from the Danish Veterinary and Food Administration (Fødevarestyrelsen) to be the only producer of bovine colostrum powder as diet supplement in Denmark. Shortly after, Biodane Pharma launches the first diet supplement with intact bovine colostrum powder: ColoDan Whole Colostrum©.
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2012
Production facilities on Biodane Pharma expands
On Biodane Pharma, the production facilities in the fabric are expanded with own dairy and special procedures are developed for the production of high quality bovine colostrum powder allowed to be used on hospitals.
First results on positive effects from bovine colostrum on intestinal dysfunction in preterm piglets
The results from the first clinical studies on bovine colostrum against intestinal dysfunction report a clear beneficial effect from bovine colostrum on the intestinal environment in the preterm piglets, based on improvements in the intestinal structure, digestive and absorptive functions, the microbiota, and by reduced level of inflammatory markers. Using the preterm piglets as animal models for preterm infant, these results strongly indicate that beneficial effects could be accomplished by using intact bovine colostrum powder as diet supplement for preterm infant when mother’s own milk is not available in sufficient amounts. The results were published in the papers Bovine colostrum improves intestinal function following formula-induced gut inflammation in preterm pigs and Spray-dried, pasteurized bovine colostrum protects against gut dysfunction and inflammtion in preterm pigs. Due to the similarity and relevance in study object and method, this PhD-project was later included in NEOMUNE.
Biodane Pharma provided the bovine colostrum used in the clinical studies.
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2008
First studies on bovine colostrum against intestinal dysfunction in preterm piglet model animals
The first studies on bovine colostrum against gastrointestinal diseases is initiated using preterm piglets with necrotizing enterocolitis as model animals for preterm infants. The aims was to investigate if bovine colostrum could correct intestinal dysfunction and reduce inflammation, if pasteurized and/or spray dried bovine colostrum had similar beneficial effects on gastrointestinal dysfunctions and inflammation as fresh bovine colostrum, and the effects of infant formula milk versus bovine colostrum on intestinal epithelial cells. The research is completed on Technical University of Denmark, Copenhagen.
Biodane Pharma provided the bovine colostrum used in the clinical studies.
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2006
The first step towards clinical studies on intact bovine colostrum as diet supplement
A cooperation between Odense University Hospital, Rigshospitalet in Copenhagen, Biodane Pharma and others is established in order to conduct ‘safety-studies’ documenting the safety and feasibility of bovine colostrum as diet supplement with no adverse effects. These studies become the later NEOMUNE and NEOCOL projects.
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2005
Beginning of partnership concerning later clinical studies of bovine colostrum
Biodane Pharma starts cooperation with professor Per T. Sangild from Copenhagen University, who is a leading scientist that focus on gastroenterology, endocrinology, immunity and nutrition in infants and animal models of infant diseases (mainly piglets). Per T. Sangild is also one of the main inventers behind the development of an international famous pig-model that simulate the gastrointestinal system in human preterm infants. The model demonstrates at bovine colostrum provided enteral may benefit the gut in preterm piglets and reduce the risk for developing necrotizing enterocolitis. The results receive massive attention international and leads to a paradigm shift in the scientific studies on the subject.
Read more about pig models in human research here.
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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.
