Growth and Tolerance of Hypoallergenic Formulas

The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.

Study Overview

• Status: Completed
• Conditions: Growth of Term Infants
• Intervention / Treatment: Other: Infant formula

• Study Type: Observational
• Enrollment (Actual): 511

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
    • Pinson, Alabama, United States, 35126
      • Pediatrics East - Alabama Clinical Therapeutics
  • Arkansas
    • Benton, Arkansas, United States, 72019
      • Central Arkansas Pediatric Clinic
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Pediatric Clinic
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, P.C.
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Altamonte Pediatric Associates
    • Plantation, Florida, United States, 33324
      • Children's Medical Association
  • Georgia
    • Dalton, Georgia, United States, 30721
      • North Georgia Clinical Research Center/White's Pediatrics
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • PTCU/Children and Youth Project
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Pediatrics
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • Woburn Pediatric Associates
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Gretchen Swanson Center for Nutrition
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Capital Pediatrics & Adolescent Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Innovis Health South University
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Red Lion Pediatrics
    • Pittsburgh, Pennsylvania, United States, 15241
      • Primary Physicians Research, Inc
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic - North Jackson
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Austin, Texas, United States, 78745
      • Austin Diagnostic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Heatly, term infants

Description

Inclusion Criteria:

• Singleton, 12-16 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula fed
• Signed Informed Consent and Protected Health Information

Exclusion Criteria:

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Marketed hypoallergenic infant formula containing a probiotic	Other: Infant formula
Experimental 1; An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control	Other: Infant formula
Experimental 2; An investigational hypoallergenic infant formula with a different protein content, without a probiotic	Other: Infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight measured at each study visit	3.5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Recall of infant formula intake at each study visit	3.5 months
Medically-confirmed adverse events collected throughout the study period	3.5 months
Body Length and Head Circumference measured at each study visit	3.5 months
Recall of stool characteristics and tolerance at each study visit	3.5 months
Parental Product Assessment Questionnaire completed at Study Visit 2	once

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition
• Investigators: Study Director: Timothy Cooper, M.D., Mead Johnson Nutrition

Publications and helpful links

General Publications

• Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 13, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 3383-1