Impact of Infant Formula on Caregiver-perceived Intolerance

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 1, 2019

Interventions

  • Other: Routine infant formula
    • Routine infant formula with probiotic

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Routine infant formula

Clinical Trial Outcome Measures

Primary Measures

  • Infant GI Symptom Burden
    • Time Frame: 3 weeks
    • Study personnel will administer questionnaire

Secondary Measures

  • Formula Intake
    • Time Frame: 24 hours
    • Caregivers will document on diary records
  • Fussiness
    • Time Frame: 24 hours
    • Caregivers will document on diary records
  • Formula Satisfaction Questionnaire
    • Time Frame: 3 weeks
    • Study personnel will administer questionnaire
  • Adverse Events
    • Time Frame: 24 hours and 3 weeks
    • Assessed throughout study

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 14 Days

Maximum Age: 60 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Société des Produits Nestlé (SPN)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ryan Carvalho, MD, Study Director, Nestle Nutrition

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