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Abstract
Grant Number: 5R21AT001486-02 Project Title: Feasibility Study of Probiotics for Growth Faltering
PI Information: Name Title WANKE, CHRISTINE A. christine.wanke@tufts.edu PROFESSOR Abstract: DESCRIPTION (provided by applicant): Diarrheal disease and growth faltering that occur at the time of weaning are significant public health problems. Malnutrition is associated with more than half of the 10 million deaths per year in children under the age of five in the developing world. Exposure to contaminants in the environment is a risk that increases at the time of weaning and is linked to an increased incidence of diarrheal disease when exclusive breast feeding is supplemented by additional foods. Many of the potential interventions for interrupting this cycle of malnutrition and diarrheal disease are not economically or technically feasible for communities in the developing world. The proposed project consists of a study that will determine the feasibility of conducting a randomized-double blinded controlled study of the probiotic Lactobacillus GG (LGG) given in yogurt to infants at the time of weaning as a culturally and economically appropriate intervention for this cycle of malnutrition and diarrhea. The proposed project will also obtain preliminary, background data on the incidence and severity of both diarrheal disease and growth faltering by weight for height and weight for age z scores before and after the time of weaning in children in a slum community in Pakistan. This study will examine the feasibility of enrolling infants at birth, following them weekly at home until the time of weaning and testing the ability to identify the time of weaning. Further, this study proposes to examine the feasibility of following children daily at home after weaning, to monitor health and nutritional status and to administer LGG in yogurt to a group of infants randomized to this intervention. The primary outcomes for the feasibility study are the ability to collect the required data on nutritional, general health, neuro-developmental status, and on the rate and duration of diarrheal disease in the community in Pakistan. Additional primary outcomes include the determination of the background rates and severity of diarrheal disease and growth faltering by height for age and weight for age z scores and the preliminary ability of LGG to ameloriate both diarrheal disease and growth faltering. These data will be used, with the feasibility data obtained, to prepare a proposal for a full clinical trial of LGG as an intervention for growth faltering and diarrheal disease at the time of weaning in these children.
Public Health Relevance:
This Public Health Relevance is not available.Thesaurus Terms:
Lactobacillus, biotherapeutic agent, dairy product, diarrhea, disease /disorder prevention /control, drug screening /evaluation, human therapy evaluation, malnutrition, postnatal growth disorder, weaning
breast feeding, developmental nutrition, diet therapy, dietary supplement, medically underserved population, southeast Asia, urban poverty area
alternative medicine, clinical research, human subject, infant human (0-1 year), nutrition related tag, outcomes research, patient oriented research
Institution: TUFTS UNIVERSITY BOSTON Office of the Vice Provost BOSTON, MA 02111 Fiscal Year: 2006 Department: NUTRITION, EXERCISE PHYSIOLOGY AND SARCOPENIA (NEPS) LABORATORY Project Start: 01-APR-2005 Project End: 31-MAR-2008 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1