Impact of Infant Formula on Caregiver-perceived Intolerance

Completed · Not applicable

Conditions studied: Healthy Infants

In brief

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

Key facts

Study ID

NCT03679234

Run by

Société des Produits Nestlé (SPN)

People needed

51

Starts

2018-09-24

Expected to finish

2019-04-01

Last updated by the study team

2020-06-09

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Norwich Pediatrics Group — Norwich, Connecticut, United States
• Qualmedica Research — Owensboro, Kentucky, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Coastal Pediatric Associates — Charleston, South Carolina, United States
• Midsouth Center for Clinical Research, LLC — Memphis, Tennessee, United States
• ClinPoint Trials — Waxahachie, Texas, United States
• Tanner Clinic — Layton, Utah, United States

Full record on ClinicalTrials.gov

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