Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
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|ClinicalTrials.gov Identifier: NCT02385773|
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea||Dietary Supplement: PTM202 Dietary Supplement: Enfamil Puramino||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||321 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind, Randomized, Placebo-Controlled Trial to Assess the Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
Dietary Supplement: PTM202
Administration of study nutritional product once per day for 3 days starting immediately after enrollment
Other Name: Conforta123
Placebo Comparator: Enfamil Puramino
Dietary Supplement: Enfamil Puramino
Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
- Duration of diarrhea [ Time Frame: Subjects will be followed for the duration of the diarrheal illness, with an expected average duration of 72 hours ]Duration in hours until subject has achieved a 12 hour period without diarrheal stools
- Weight gain after diarrhea [ Time Frame: 2 weeks ]Weight will be assessed 14 days after the day 3 rehydrated baseline weight
- Weight gain after diarrhea [ Time Frame: 4 weeks ]Weight will be assessed 28 days after the day 3 rehydrated baseline weight
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385773
|Clínicas del Centro de Desarrollo Humano|
|Guatemala City, Guatemala|
|Principal Investigator:||James T Gaensbauer, MD||University of Colorado, Denver|