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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

Tracking Information
First Submitted Date  ICMJE February 6, 2015
First Posted Date  ICMJE March 11, 2015
Last Update Posted Date January 6, 2017
Study Start Date  ICMJE March 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diarrhea
Intervention  ICMJE
  • Dietary Supplement: PTM202
    Administration of study nutritional product once per day for 3 days starting immediately after enrollment
    Other Name: Conforta123
  • Dietary Supplement: Enfamil Puramino
    Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
Study Arms  ICMJE
  • Experimental: PTM202
    PTM202
    Intervention: Dietary Supplement: PTM202
  • Placebo Comparator: Enfamil Puramino
    Formal Placebo
    Intervention: Dietary Supplement: Enfamil Puramino
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2017)
321
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2015)
600
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02385773
Other Study ID Numbers  ICMJE 14-1372
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Colorado, Denver
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Colorado, Denver
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE PanTheryx, Inc.
Investigators  ICMJE
Principal Investigator: James T Gaensbauer, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP