Back to resultsImpact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
Primary Purpose
Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
PTM202
Enfamil Puramino
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring colostrum, Immunoglobulin Y (IgY)
Eligibility Criteria
Inclusion Criteria:
- Subject's parent or legal guardian is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 6 months to 35 months.
- Presenting to care for acute diarrhea of 72 hours duration or less at the time of enrollment.
- Greater than 3 liquid stools in the previous 24 hours.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Additional inclusion for Arm 1: in addition to above, the subject will require or have already required > 8 hours of active rehydration in hospital or ER diarrheal ward, as determined by the attending physician.
- Additional inclusion for Arm 2: in addition to above, the subject will require or have already required < 8 hours of active rehydration in hospital or ER diarrheal ward, as determined by the attending physician.
Exclusion Criteria:
- Clinical condition for which oral intake of test product or placebo is contraindicated in opinion or attending physician.
- History of hypersensitivity or adverse reaction to milk or egg products.
- Condition improving in last 24 hours per parental report.
- Mild disease severity, defined as no recommended period of observed rehydration therapy per attending physician.
- Bloody Diarrhea at presentation.
- Severe malnutrition, defined as weight-for-age Z-score < -3 from median WHO published norms.
- Major congenital defects or serious chronic illness (neurologic, pulmonary, gastrointestinal liver, renal or endocrine).
- Receipt of probiotics in 72 hours prior to enrollment or recommended treatment with probiotics by attending physician
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
- Subject who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol, including capability to receive follow-up telephone calls or return for final visit.
Sites / Locations
- Clínicas del Centro de Desarrollo Humano
- Hospital Roosevelt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PTM202
Enfamil Puramino
Arm Description
PTM202
Formal Placebo
Outcomes
Primary Outcome Measures
Duration of diarrhea
Duration in hours until subject has achieved a 12 hour period without diarrheal stools
Secondary Outcome Measures
Weight gain after diarrhea
Weight will be assessed 14 days after the day 3 rehydrated baseline weight
Weight gain after diarrhea
Weight will be assessed 28 days after the day 3 rehydrated baseline weight
Full Information
NCT ID
NCT02385773
First Posted
February 6, 2015
Last Updated
January 4, 2017
Sponsor
University of Colorado, Denver
Collaborators
PanTheryx, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02385773
Brief Title
Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
PanTheryx, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
colostrum, Immunoglobulin Y (IgY)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTM202
Arm Type
Experimental
Arm Description
PTM202
Arm Title
Enfamil Puramino
Arm Type
Placebo Comparator
Arm Description
Formal Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
PTM202
Other Intervention Name(s)
Conforta123
Intervention Description
Administration of study nutritional product once per day for 3 days starting immediately after enrollment
Intervention Type
Dietary Supplement
Intervention Name(s)
Enfamil Puramino
Intervention Description
Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
Primary Outcome Measure Information:
Title
Duration of diarrhea
Description
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
Secondary Outcome Measure Information:
Title
Weight gain after diarrhea
Description
Weight will be assessed 14 days after the day 3 rehydrated baseline weight
Time Frame
2 weeks
Title
Weight gain after diarrhea
Description
Weight will be assessed 28 days after the day 3 rehydrated baseline weight
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject's parent or legal guardian is willing and able to give informed consent for participation in the trial.
Male or Female, aged 6 months to 35 months.
Presenting to care for acute diarrhea of 72 hours duration or less at the time of enrollment.
Greater than 3 liquid stools in the previous 24 hours.
In the Investigator's opinion, is able and willing to comply with all trial requirements.
Additional inclusion for Arm 1: in addition to above, the subject will require or have already required > 8 hours of active rehydration in hospital or ER diarrheal ward, as determined by the attending physician.
Additional inclusion for Arm 2: in addition to above, the subject will require or have already required < 8 hours of active rehydration in hospital or ER diarrheal ward, as determined by the attending physician.
Exclusion Criteria:
Clinical condition for which oral intake of test product or placebo is contraindicated in opinion or attending physician.
History of hypersensitivity or adverse reaction to milk or egg products.
Condition improving in last 24 hours per parental report.
Mild disease severity, defined as no recommended period of observed rehydration therapy per attending physician.
Bloody Diarrhea at presentation.
Severe malnutrition, defined as weight-for-age Z-score < -3 from median WHO published norms.
Major congenital defects or serious chronic illness (neurologic, pulmonary, gastrointestinal liver, renal or endocrine).
Receipt of probiotics in 72 hours prior to enrollment or recommended treatment with probiotics by attending physician
Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
Subject who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol, including capability to receive follow-up telephone calls or return for final visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James T Gaensbauer, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínicas del Centro de Desarrollo Humano
City
Coatepeque
Country
Guatemala
Facility Name
Hospital Roosevelt
City
Guatemala City
Country
Guatemala
12. IPD Sharing Statement
Citations:
PubMed Identifier
29259822
Citation
Gaensbauer JT, Melgar MA, Calvimontes DM, Lamb MM, Asturias EJ, Contreras-Roldan IL, Dominguez SR, Robinson CC, Berman S. Efficacy of a bovine colostrum and egg-based intervention in acute childhood diarrhoea in Guatemala: a randomised, double-blind, placebo-controlled trial. BMJ Glob Health. 2017 Dec 4;2(4):e000452. doi: 10.1136/bmjgh-2017-000452. eCollection 2017.
Results Reference
derived
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Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
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