Acceptance Of A Partially-Hydrolyzed Infant Formula

January 7, 2019 updated by: Mead Johnson Nutrition
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Pediatric Associates
      • Dothan, Alabama, United States, 36305
        • Southeastern Pediatric Associates
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Northwest Arkansas Pediatric Clinic
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro, P.A.
    • Indiana
      • Evansville, Indiana, United States, 47725
        • Deaconess Clinical Research
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatrics/Adult Research
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Pediatrics
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research
    • Texas
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 9 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton 28-300 days of age at randomization
  • Gestational age less than or equal to 35 weeks
  • Receiving minimum 18oz infant formula in the 24hrs prior to randomization
  • History of hard stools or stooling difficulty
  • Signed informed consent and protected health information

Exclusion Criteria:

  • Current diagnosis of cow's milk protein allergy or intolerance
  • Use of extensively hydrolyzed or amino acid formula at randomization
  • Any abdominal or gastrointestinal surgery prior to randomization
  • History of underlying metabolic or chronic disease or congenital malformation
  • Organic causes of constipation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: Control
Routine cow's milk-based infant formula
Experimental: Investigational
Other: Investigational
Partially-hydrolyzed cow's milk protein infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool consistency measured by MJN stool consistency scale
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Stool frequency
Time Frame: 14 days
14 days
Formula acceptance measured by intake diary
Time Frame: 14 days
14 days
Formula gastrointestinal tolerance measured by diary
Time Frame: 14 days
14 days
Bowel movement characteristics by diary
Time Frame: 14 days
14 days
Medically confirmed adverse events throughout the study period
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 3389-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stool

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe