Previous studies have shown pregelatinized starch to be effective in the symptomatic treatment of common diarrhea in neonatal calves, and Shulcon Industries, Inc. now markets a product in Canada for that purpose. This project will extend the antidiarrheal application of pregelatinized starch to a second, monogastric, animal species leading to the development of an antidiarrheal drug applicable to human infants. Phase I will establish the efficacy of pregelatinized starch in treating specific acute neonatal pig diarrhea as a model for the human infantile disease. Selected strains.of enterotoxigenic E. coli with differing pilus antigens will be employed independently to challenge newborn pigs from non-immunized gilts to produce diarrheal disease. Diarrheic pigs will be assigned randomly to treatment or placebo groups in a double blind design, treated accordingly and observed for up to seven days. Form of stool and frequency of defecation will be monitored to establish the duration of diarrhea. Body weight and clinical hydration state will be determined daily as independent measures of the effect of the therapeutic method.Randomly selected pigs will be sacrificed one day after completion of the therapeutic series and the sizes of the populations of the challenge strain adhering to the intestinal mucosa will be determined. Histochemical examination of sections from segments of the small intestine will evaluate the passage and locus of starch throughout that organ. Necropsies will be performed on all pigs that die during the study.The output of the study will be a measure of the effectiveness of pregelatinized starch in arresting specific acute diarrhea of neonatal pigs due to several piliated types of E. coli and will determine the appropriateness of proceeding to more complete pre@i i@cal studies to establish mechanistics and animal safety prior to clinical studies in humans.National Institute of Arthritis, Diabetes and Digestive and Kidney Diseases
