Gastrointestinal Tolerance Evaluation of an Infant Formula

Infant Formula GI Tolerance Evaluation

Prospective, double-blind, randomized study of 2 infant formulas.

Study Overview

• Status: Completed
• Conditions: Healthy, Full-term Infants Who Are Formula-fed
• Intervention / Treatment: Other: Routine Infant Formula 1; Other: Routine Infant Formula 2

Detailed Description

Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Bluegrass Clinical Research, Inc.
    • Owensboro, Kentucky, United States, 42310
      • PediaResearch
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Midsouth Center for Clinical Research, LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy newborn singleton infant
• Full-term (> 37 weeks gestation)
• Birth weight ≥ 2500 grams and ≤ 4500 grams
• 9-19 days of age on enrollment
• Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Known or suspected cow-milk allergy
• Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
• Currently not tolerating (as perceived by the caregiver) their formula
• Currently being treated for reflux
• Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
• Congenital illness or malformation that may affect infant feeding and/or growth
• Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
• Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
• Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
• Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Infant Formula 1; Routine infant formula with probiotic	Other: Routine Infant Formula 1; Routine infant formula with probiotic
Active Comparator: Routine Infant Formula 2; Routine infant formula with probiotic and prebiotic	Other: Routine Infant Formula 2; Routine infant formula with probiotic and prebiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant GI Symptom Burden	Study personnel will administer questionnaire	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool pattern	Caregivers will document on diary records	6 weeks
Spit-up and/or vomiting pattern	Caregivers will document on diary records	6 weeks
Crying and fussing duration	Caregivers will document on diary records	6 weeks
Formula intake	Caregivers will document on diary records	6 weeks
Formula satisfaction questionnaire	Study personnel will administer questionnaire	6 weeks
Weight (measured in grams)	Study personnel will measure	Enrollment and 6 weeks
Length (measured in centimeters)	Study personnel will measure	Enrollment and 6 weeks
Adverse events	Assessed throughout study	2 weeks and 6 weeks

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Director: Ryan Carvalho, MD, Nestle Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): January 19, 2018
• Study Completion (Actual): January 19, 2018

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17.01.US.INF

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