This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will enroll children between the ages of 6 months and 3 years and will assess the impact of the study nutrition product on the duration and severity of diarrhea and on weight recovery in the 4 weeks following the diarrheal episode. The investigators will be determining the etiology of the diarrhea episode to ascertain if the nutritional product works better for certain etiologies or has a non-specific benefit.
This is a double-blind, randomized control trial of the nutritional product PTM202, which is a food product based on cow milk colostrum and eggs from hens that have been immunized against human diarrheal pathogens. Children between the ages of 6 months and 3 years will be enrolled at two sites in Guatemala who present with acute diarrhea. The study will have two strata according to the severity of the diarrhea. The study product will be administered over 3 days, and the investigators will assess the impact on diarrhea duration and severity, and then follow subjects for 4 weeks to assess the impact of the nutritional product on weight gain following the episode, because poor weight gain is a major health problem in low-income countries. The investigators will also monitor for any adverse events during the trial. The duration of participation will be 31 days for all subjects. A stool sample will be collected at enrollment to ascertain the etiology of the diarrhea. A second sample will be collected at the end of the study to assess changes in pathogens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
321
Administration of study nutritional product once per day for 3 days starting immediately after enrollment
Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
Clínicas del Centro de Desarrollo Humano
Coatepeque, Guatemala
Hospital Roosevelt
Guatemala City, Guatemala
Duration of diarrhea
Duration in hours until subject has achieved a 12 hour period without diarrheal stools
Time frame: Subjects will be followed for the duration of the diarrheal illness, with an expected average duration of 72 hours
Weight gain after diarrhea
Weight will be assessed 14 days after the day 3 rehydrated baseline weight
Time frame: 2 weeks
Weight gain after diarrhea
Weight will be assessed 28 days after the day 3 rehydrated baseline weight
Time frame: 4 weeks
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