Much has been learned in recent years about the mechanisms by which breastfeeding improves child health and survival. However, there has been little progress in using these insights to improve pediatric care. Factors that are important for protecting the breast fed infant might be expected to decrease the adverse effects of weaning on diarrhea, growth, and development. The proposed study is meant to begin addressing this important gap by a clinical trial of lactoferrin supplementation in previously weaned children. Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those consumed if the child were still breast fed) will improve health by mimicking its protective roles in milk. There is a vast literature showing in vitro and animal model benefits of lactoferrin. For the last 27 years we have been working on understanding the protective factors in milk. Our recent studies have focused on lactoferrin. We have found that lactoferrin not only inhibits growth;it impairs virulence by causing loss of attachment/invasion structures in multiple bacterial enteropathogens. The proposed community-based study will be conducted in a previously weaned population at risk for repeated intestinal infections. Infants who are 12-24 months of age living in the District of Independencia, Lima, Peru will be eligible for enrollment. We will conduct a randomized double blind placebo controlled trial comparing twice daily supplementation with bovine lactoferrin versus a placebo (maltodextrin). Therapy will be continued for 12 months with close monitoring of all study participants for diarrhea and growth.
Specific aim 1 : Determine the effect of bovine lactoferrin supplementation on prevention of diarrhea, measured by the number of episodes of diarrhea during a 12 month trial in previously weaned Peruvian children enrolled at 12 to 24 months of age.
Specific aim 2 : Determine the effect of bovine lactoferrin supplementation on growth. The significance of these studies is that they will prove feasibility of improving child health after the end of breastfeeding by continuing ingestion of a major protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may be amenable to this approach.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD051716-04
Application #
7802315
Study Section
Clinical Research and Field Studies of Infectious Diseases Study Section (CRFS)
Program Officer
Raiten, Daniel J
Project Start
2007-08-29
Project End
2011-11-30
Budget Start
2010-06-01
Budget End
2011-11-30
Support Year
4
Fiscal Year
2010
Total Cost
$244,673
Indirect Cost
Name
University of Texas Health Science Center Houston
Department
Internal Medicine/Medicine
Type
Schools of Public Health
DUNS #
800771594
City
Houston
State
TX
Country
United States
Zip Code
77225
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Durand, David; Contreras, Carmen A; Mosquito, Susan et al. (2016) pic gene of enteroaggregative Escherichia coli and its association with diarrhea in Peruvian children. Pathog Dis 74:
Medina, Anicia M; Rivera, Fulton P; Pons, Maria J et al. (2015) Comparative analysis of antimicrobial resistance in enterotoxigenic Escherichia coli isolates from two paediatric cohort studies in Lima, Peru. Trans R Soc Trop Med Hyg 109:493-502
Lluque, Angela; Mosquito, Susan; Gomes, Cláudia et al. (2015) Virulence factors and mechanisms of antimicrobial resistance in Shigella strains from periurban areas of Lima (Peru). Int J Med Microbiol 305:480-90
Chang, Millie R; Velapatiño, Grace; Campos, Miguel et al. (2015) Rotavirus seasonal distribution and prevalence before and after the introduction of rotavirus vaccine in a peri-urban community of Lima, Peru. Am J Trop Med Hyg 92:986-8
Coveñas, Cecilia; Dextre, Georgette; Fernandez, Diana et al. (2014) [Effect of bovine lactoferrin biofilms in the formation of clinical strains of enteroaggregative E. coli]. Rev Peru Med Exp Salud Publica 31:454-60
Ochoa, Theresa J; Chea-Woo, Elsa; Baiocchi, Nelly et al. (2013) Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children. J Pediatr 162:349-56
Barletta, Francesca; Ochoa, Theresa J; Cleary, Thomas G (2013) Multiplex real-time PCR (MRT-PCR) for diarrheagenic. Methods Mol Biol 943:307-14
Barletta, F; Mercado, E H; Lluque, A et al. (2013) Multiplex real-time PCR for detection of Campylobacter, Salmonella, and Shigella. J Clin Microbiol 51:2822-9
Contreras, C A; Ochoa, T J; Ruiz, J et al. (2012) Genetic diversity of locus of enterocyte effacement genes of enteropathogenic Escherichia coli isolated from Peruvian children. J Med Microbiol 61:1114-20

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