NCT02385773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

February 6, 2015

Last Update Submit

January 4, 2017

Conditions

Diarrhea

Keywords

colostrumImmunoglobulin Y (IgY)

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhea

    Duration in hours until subject has achieved a 12 hour period without diarrheal stools

    Subjects will be followed for the duration of the diarrheal illness, with an expected average duration of 72 hours

Secondary Outcomes (2)

  • Weight gain after diarrhea

    2 weeks

  • Weight gain after diarrhea

    4 weeks

Study Arms (2)

PTM202

EXPERIMENTAL

PTM202

Dietary Supplement: PTM202

Enfamil Puramino

PLACEBO COMPARATOR

Formal Placebo

Dietary Supplement: Enfamil Puramino

Interventions

PTM202DIETARY_SUPPLEMENT

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

Also known as: Conforta123
PTM202
Enfamil PuraminoDIETARY_SUPPLEMENT

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

Enfamil Puramino

Eligibility Criteria

Age12 Months - 35 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ClĂ­nicas del Centro de Desarrollo Humano

Coatepeque, Guatemala

Location

Hospital Roosevelt

Guatemala City, Guatemala

Location

Related Publications (1)

  • 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.

    PMID: 29259822DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James T Gaensbauer, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

GU(2)