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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02385773
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
PanTheryx, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: PTM202 Dietary Supplement: Enfamil Puramino Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: PTM202
PTM202
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
Formal Placebo
Dietary Supplement: Enfamil Puramino
Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Weight gain after diarrhea [ Time Frame: 2 weeks ]
    Weight will be assessed 14 days after the day 3 rehydrated baseline weight

  2. Weight gain after diarrhea [ Time Frame: 4 weeks ]
    Weight will be assessed 28 days after the day 3 rehydrated baseline weight



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Guatemala
Clínicas del Centro de Desarrollo Humano
Coatepeque, Guatemala
Hospital Roosevelt
Guatemala City, Guatemala
Sponsors and Collaborators
University of Colorado, Denver
PanTheryx, Inc.
Investigators
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Principal Investigator: James T Gaensbauer, MD University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02385773    
Other Study ID Numbers: 14-1372
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Keywords provided by University of Colorado, Denver:
colostrum
Immunoglobulin Y (IgY)
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive