Impact of Infant Formula on Caregiver-perceived Intolerance

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Study Overview

• Status: Completed
• Conditions: Healthy Infants
• Intervention / Treatment: Other: Routine infant formula

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatrics Group
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research
  • 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
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Healthy infant
• Full-term (> 37 weeks gestation)
• Birth weight > 2500 and < 4500 g
• 14-60 days of age on enrollment
• Singleton birth
• Infant's mother has elected not to breastfeed prior to enrollment
• Infant exclusively formula-fed for at least 5 days prior to enrollment
• Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
• Caregiver wishes to switch infant's formula
• Has not received solid foods
• 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. thickened, extensively hydrolyzed, amino acid-based, metabolic)
• Has switched formula more than two times since hospital discharge
• Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing 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 probiotic supplements
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Routine infant formula	Other: Routine infant formula; Routine infant formula with probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant GI Symptom Burden	Study personnel will administer questionnaire	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula Intake	Caregivers will document on diary records	24 hours
Fussiness	Caregivers will document on diary records	24 hours
Formula Satisfaction Questionnaire	Study personnel will administer questionnaire	3 weeks
Adverse Events	Assessed throughout study	24 hours and 3 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 24, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18.01.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