Assessing Early Behavioral Indicators of Formula Tolerance

September 13, 2016 updated by: Mead Johnson Nutrition
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

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
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Nutrition Research Center

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

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton at birth
  • Term infant with birth weight of 2500 g or more
  • Crying or fussing for 3 or more hours per day
  • Consuming mostly infant formula
  • Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

  • Current use of extensively hydrolyzed or amino acid infant formula
  • Planned use of probiotics during the study
  • History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
  • Enrollment in another interventional clinical research study

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Marketed partially hydrolyzed cow's milk protein infant formula
Other: Control
Marketed partially hydrolyzed cow's milk protein infant formula
Experimental: Investigational
Partially hydrolyzed cow's milk infant formula with a probiotic
Other: Investigational
Partially hydrolyzed cow's milk protein infant formula with a probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant Behavior Diary
Time Frame: 21 Days
21 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Recall of Tolerance Questionnaire
Time Frame: Baseline and Day 21
Baseline and Day 21
Body Weight
Time Frame: Baseline and Day 21
Baseline and Day 21
Infant Behavior Questionnaire - Revised
Time Frame: Baseline and Day 21
Baseline and Day 21
Recall of formula intake at each visit
Time Frame: Baseline, Day 10, and Day 18
Baseline, Day 10, and Day 18
Fecal microbiome and Fecal calprotectin
Time Frame: Baseline and Day 21
Baseline and Day 21
Medically-confirmed Adverse Events
Time Frame: 21 Days
21 Days

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Collaborators

Baylor College of Medicine

Investigators

  • Study Director: Carol Lynn Berseth, M.D., Mead Johnson Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 6025

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.

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