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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