281. Efficacy of a Novel Nutritional Product in Acute Childhood Diarrhea in Guatemala: Secondary and Exploratory Analyses of a Randomized, Double Blind, Placebo Controlled Trial.
Session: Poster Abstract Session: Global Health Potpourri
Thursday, October 5, 2017
Room: Poster Hall CD

Background: PTM202 is a nutritional intervention for acute diarrhea that combines bovine colostrum with egg produced by hens vaccinated with USDA approved vaccines to standardize the levels of pathogen-specific immunoglobulin-Y, which target rotavirus, enterotoxigenic E.coli, shigatoxin + E.coli and Salmonella. In a randomized, double-blind, placebo-controlled trial, PTM202 shortened acute non-bloody diarrhea in Guatemalan children who had ≥ 1targeted organism in stool. To further define the clinical relevance of these findings, we conducted secondary and exploratory analyses of study outcomes.

Methods: From 3/2015 to 1/2016, 323 children 6—35 months with acute non-bloody diarrhea were randomized at 3 sites (1 rural, 2 urban) to one oral dose daily for 3 days of study product or placebo.  Diarrheal pathogens on Day 1 were determined by multiplex PCR (FilmArray GI Panel, BioFire, USA). Product efficacy on diarrheal resolution (last diarrheal stool prior to formed or no stool in 12 hours) at days 1, 2, 3 and 7 after the initial dose, and 2 and 4 week weight recovery were assessed. Analyses were stratified by site and presence of targeted organisms. 

Results: In urban patients with at least one targeted organism, statistically significant efficacy of the study product was noted at 1, 2 and 3 days (Table).  No effect was demonstrated in analysis of all subjects, or in subjects with targeted organisms from the rural area (who had more targeted and non-targeted stool pathogens and poorer nutritional status).  No impact of study treatment on 2 or 4 week weight gain was noted in overall or stratified analyses.

Conclusion: PTM202 appears to shorten diarrheal duration in children with targeted stool pathogens, and may add to the therapeutic armamentarium against one of the major global causes of pediatric morbidity. Exploratory analysis suggests that 3 doses may not be required for efficacy–which would be a tremendous advantage for taking this treatment to scale in low and middle income countries–and will form the basis of future clinical trials.

Table: Efficacy at days 1, 2, 3 and 7 after 1ststudy dose:  urban children with ≥ 1 targeted pathogen

Day

% Resolved Diarrhea

PTM202

Placebo

Efficacy

p (chi2)

   1

56.0

25.0

41%

0.021

   2

88.0

64.3

66%

0.045

   3

96.0

71.4

86%

0.026

   7

100.0

89.3

100%

0.092

 

James Gaensbauer, MD, MScPH1,2,3,4,5, Mario Melgar, MD6, Molly Lamb, PhD3,4, Diva M Calvimontes, MD6, Edwin J Asturias, MD1,3,4, Ingrid Contreras-Roldan, MD7, Samuel Dominguez, MD, PhD8,9, Christine C. Robinson, PhD9 and Stephen Berman, MD4, (1)Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, (2)Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO, (3)Department of Epidemiology, Colorado School of Public Health, Aurora, CO, (4)Center for Global Health, Colorado School of Public Health, Aurora, CO, (5)Pediatric Infectious Disease, Denver Health and Hospital Authority, Denver, CO, (6)Hospital Roosevelt, Guatemala City, Guatemala, (7)Universidad del Valle de Guatemala, Guatemala City, Guatemala, (8)Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, (9)Department of Pathology and Laboratory Medicine, Children’s Hospital Colorado, Aurora, CO

Disclosures:

J. Gaensbauer, PanTheryx, Inc: Grant Investigator and Investigator , Research grant

M. Melgar, PanTheryx, Inc: Investigator , Research grant

M. Lamb, PanTheryx, Inc: Investigator , Research grant

D. M. Calvimontes, PanTheryx, Inc: Investigator , Research grant

E. J. Asturias, PanTheryx: Investigator , Research grant

I. Contreras-Roldan, PanTheryx: Investigator , Research grant

S. Dominguez, PanTheryx, Inc: Investigator , Research support

C. C. Robinson, None

S. Berman, PanTheryx: Investigator , Research grant

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