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Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease

NCT02385773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2017-01-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

PTM202

Administration of study nutritional product once per day for 3 days starting immediately after enrollment

DIETARY_SUPPLEMENT

Enfamil Puramino

Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment

Sponsors & Collaborators

  • PanTheryx, Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • James T Gaensbauer, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • Guatemala

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385773 on ClinicalTrials.gov