Research

Longitudinal Study of the Immunological Properties of Milk
A study examining the immunological properties of milk longitudinally as a function of the time post-partum that the milk was expressed. This study may provide support for the utilization of milk from donors expressing after one year or more post-partum. (Churchill Hospital/Oxford University)

Rechtman DJ, Ferry B, Lee ML, and Chapel H. IgA content of human breast milk over time Presented at 12th International Symposium on Infections in the Immunocompromised Host Halifax Nova Scotia Canada June 2002

Pasteurization Validation
The high temperature short time (HTST) pasteurization process utilized by Prolacta was validated in four studies completed by the Central Laboratory of Dutch Red Cross (Sanquin). Whole pasteurized human milk and versions of our preliminary fortifier were evaluated. The results demonstrated a complete kill of HIV, HBC and HCV (>5.8->7.7 logs). It also showed a kill of HAV (>2.6 logs) using HTST. Finally a complete bacterial kill (E. coli, S. aureus, and S. agalactiae: (>15 logs->32logs) was shown.¹ Similar data was also obtained as part of the same set of experiments for a vat pasteurization process also used by Prolacta.²

¹ Terpstra FG, Rechtman DJ, Lee ML, Van HoeJ K, Berg H, Van Engelenberg FAC, Van’t Wout AB. “Antimicrobial and antiviral effect of high-temperature short-time pasteurization applied to human milk.” Breastfeeding Medicine 2007, 2(1) 27-33

² Data on file, Prolacta Bioscience (2002-2005)

IgA Over Time
The major milk components study is being performed at Churchill/Radcliffe Hospital associated with Oxford University, UK. This study is evaluating the total sIgA and specific IgA antibodies pre/post-pasteurization. Data to date suggests that sIgA levels in total vary among donors over time, but certain specific antibodies tend to stay high. Continued work will evaluate various specific sIgA antibodies to pathogens associated with necrotizing enterocolitis from longitudinally collected donor milk. This research will lead to a better understanding of the change in milk composition over time.

This study is ongoing.

Human Milk Stability
This formal experiment completed over a 12 month real-time period examined vitamins, lipid oxidation, and protein content of pasteurized whole milk stored at -20°C. Results showed stability for at least 12 months of storage. Data on file, Prolacta Bioscience (2007)

An accelerated study of the stability of Prolact-Plus and milk products with a higher fat content indicated that these preparations could be stored for up to 12 months at -20 deg C without any untoward effect, particularly with regards to lipid oxidation. Data on file, Prolacta Bioscience (2007)

An evaluation of cold-chain stability was also conducted. Raw milk was subjected to several storage conditions, including thawing and refreezing. The finding showed that under laboratory conditions milk can be stored at 8°C for 24 hours or 23°C for 4 hours and can be refrozen up to three times with no significant bacterial growth.

Rechtman DJ, Lee ML and Berg H. Effect of environmental conditions on unpasteurized donor human milk. Breastfeeding Medicine 1:2006;24-26

Biological Activity Study
A comparison of ProlactPlus with cow’s milk-based fortifier in terms of their effect on the antimicrobial properties of breast milk. The study showed that the inherent anti—microbial effect of breast milk was almost totally eliminated by the addition of a commonly used cow’s milk-based fortifier to the breast milk. No measurable decrease in activity was seen when ProlactPlus was added to the breast milk.

Chan GM, Lee ML, and Rechtman DJ. “Effects of a human-milk derived human milk fortifier on the antibacterial actions of human milk” Breastfeeding Medicine Breastfeeding Medicine. 2007, 2(4): 205-208.

Clinical Research Program
The goal of this study was to evaluate the short-term effect of Prolact-Plus fortified human milk on parameters such as feeding tolerance, growth, infection rate and NEC rate. The data on Prolact-Plus was obtained prospectively from infants who received human milk fortified in this fashion. The study is now complete and the data are under review. Preliminary review indicates adequate growth and safety.

Sullivan S, White R, Christensen R, Rechtman D, Lee M, Pagan S, and Auerbach R for The Prolacta Cohort Study Group. Use of a breast milk-based human milk fortifier in VLBW infants compared with standard bovine milk-based formula; a cohort study. Presented at 12th Annual International Meeting Academy of Breastfeeding Medicine, Fort Worth, Texas October 2007

Clinical Study of Human Milk Fortifier Comparison
A randomized prospective clinical study comparing human-based fortification of mother's own milk with the standard bovine-based fortifier or, for those infants whose mothers cannot provide any breast milk a study of entirely bovine versus entirely human-based nutrition. The goal is to evaluate feeding tolerance as measured by days on total parenteral nutrition in these babies. Secondary outcomes include growth, incidence of sepsis, incidence of NEC and pharmacoeconomic parameters. This study is currently ongoing in numerous academic centers in the US and in Europe.

An observational study on the use of ProlactPlus in babies who have had long term failure to thrive due to inability to tolerate standard feedings or supplements.

Study Ongoing - multicenter

For further information: click here

A controlled clinical trial of the effect of bovine fortifiers vs. ProlactPlus on fractional calcium uptake from the gut and on bone.

Study ongoing – Baylor College of Medicine

Forthcoming

Variability in the levels of important immunological components of Milk:
A laboratory study examining the variability in the levels of important immunological components of milk such as complement and the application to the clinical treatment of autoimmune diseases. (Central Hospital of the University of Vaudois, Lausanne, Switzerland)

A trial looking at the nutritional content of breast milk actually fed to very low birth weight infants in the NICU:
As a result of real-life factors in the NICU, babies seldom receive milk representing a true 24 hour collection from their mothers on which all assumptions about nutritional content are based. This study will address the issue of the actual nutrition received by these babies.

Protocol in preparation.

Scientific Advisory Board

	Lars A. Hanson M.D., Ph.D. Professor Hanson obtained his M.D. at the School of Medicine at the University of Göteborg, Sweden in 1961 and defended his thesis for a doctoral degree in medical science, also in 1961 (Ph.D.). Dr. Hanson took graduate training at, among other institutions, Department of Bacteriology, University of Göteborg (Professor Ö. Ouchterlony), Service de Chimie Microbienne at the Pasteur Institute in Paris (Professor P. Grabar), and the Department of Protein Metabolism at the Rockefeller University, New York, USA (Professor H.G. Kunkel). Prof. Hanson joined the faculty at the University of Göteborg in 1969. From 1977 he served as Specialist in Clinical Immunology and Physician-in-Chief for Clinical Immunology for the hospitals of the City of Göteborg. In 1978 he was appointed Professor and Chairman of Clinical Immunology and Head of the Department of Clinical Immunology at the University of Göteborg. Dr, Hanson has been and continues to be Scientific Advisor in Clinical Immunology to the Swedish National Board of Health and Welfare. He is also a Fellow of the International Society of Human Milk and Lactation. He has published some 700 scientific papers in bacteriology, pediatrics and immunology; of these more than 430 are original reports. He has also been Editor or contributor/author of 21 books. Dr. Hanson has been the recipient of numerous awards and prizes.
	Cheston M. Berlin M.D. Professor Berlin received his MD degree at the Harvard University School of Medicine in 1962. His post-graduate training at Children’s Hospital Medical Center, Boston was interrupted by a stint as Senior Assist. Surgeon, US Public Health Service. Laboratory of Biochemical Pharmacology National Institute of Arthritis and Metabolic Disease National Institutes of Health Bethesda, Maryland. Dr. Berlin began his academic medical career as Assistant Professor of Pediatrics University of Alabama Medical Center, Birmingham, Alabama in 1967. He has served in various capacities at George Washington University School of Medicine, Washington DC until 1971 when he landed at the Pennsylvania State University College of Medicine, Hershey, Pennsylvania where he has been ever since. In 1986 he attained his current position of University Professor of Pediatrics. Dr. Berlin is a Fellow of the American Academy of Pediatrics and has served as Chair of several of its subcommittees. He has also served on the United States Pharmacopeia and chaired its Immunizing Agents Expert Committee, Council of Experts. Dr. Berlin is also a Fellow of the International Society for Research on Human Milk and Lactation. Dr. Berlin has published over 100 original articles and 12 statements from the Committee on Drugs of the American Academy of Pediatrics while he was chair. He is the recipient of numerous awards.
	Anders Fasth M.D., Ph.D. Professor Fasth obtained his M.D. at the School of Medicine at the University of Göteborg, Sweden in 1971 and defended his thesis for a doctoral degree in medical science, in 1980 (Ph.D.) Dr. Fasth took his postgraduate training at the University of Göteborg, the University of Lund, Sweden, the Institute of Child Health, University of London, England, and at UCLA. Professor Fasth joined the faculty at the University of Göteborg, in 1982 and has remained there in various capacities ever since. He currently is a full Professor of Immunology and head of the Pediatric Immunology and Stem Cell Transplantation Team. He has also been involved with heath care issues in Costa Rica, where he has served as advisor to the Minister of Health and continues to serve as a Consultant Immunologist at the National Children’s Hospital in San Jose. Dr. Fasth is currently Chair of the Expert Working Group for Rare Disorders of the Swedish National Health and Welfare board and of the Educational Working Party of the European Society for Immunology in addition to other committee and organizational memberships. Dr, Fasth has published over 150 publications in various areas within immunology. He has been the recipient of several awards and honors.
	Stephen A. Zinner M.D. Professor Zinner received his MD degree from University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania in 1965. He took his post-graduate training at University of Chicago Medical School and at Harvard, working at the Channing Laboratory. Dr. Zinner began his academic career at Harvard Medical school in 1971. In 1972 he accepted an appointment on the faculty at Brown University in Providence, Rhode Island. With but a few gaps Dr. Zinner has spent the last thirty-odd years affiliate with one or both of these institutions, and as Chief of Infectious Diseases at Brown. He is now Chair of the Department of Medicine at Mt. Auburn Hospital, Cambridge, MA and Charles S. Davidson Professor of Medicine at the Harvard Medical School.. He has been a visiting Professor at, among other institutions, Université Libre de Bruxelles, Institute Jules Bordet, Brussels, Belgium and Wilhelm Pieck University, Rostock, DDR as well as chairing innumerable international conferences or sessions in the area of infectious diseases. He has also served as a site visitor and Scientific Review Committee member of various units of the National Institutes of Health. Prof. Zinner has authored almost 130 original articles and 24 proceedings of international meetings. In addition to numerous book chapters he has authored or edited ten books. Dr. Zinner has been the recipient of multiple awards and prizes.
	Carl Muchnick M.D. Dr. Muchnick received his MD degree from the University of California at Los Angeles in 1969. He took his post-graduate training at the Rochester General Hospital in Rochester, New York and at the Children’s Hospital of Los Angeles in Los Angeles CA. Following completion of his training, Dr. Muchnick spent four years in the Epidemiology Intelligence Service of the Centers for Disease Control and Prevention, stationed both in the US (Texas) and abroad (El Salvador). Since that time Dr. Muchnick has been in private practice of Pediatrics. He has served as Medical Director and Chief of Pediatrics for a multi-specialty practice group. Presently he serves as Chief of Pediatrics at Torrance Memorial Hospital in Torrance CA. Dr. Muchnick has been heavily involved in the promotion of breastfeeding and serves as a Medical Affiliate to La Leche League International.