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OpenTrials
Completed

NCT Number: NCT03679234

Impact of Infant Formula on Caregiver-perceived Intolerance

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

Completed

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Key information

Conditions

Healthy Infants

Age range

14 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwich Pediatrics Group, Norwich, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine infant formula

Other

Routine infant formula with probiotic

Primary outcomes

  1. Infant GI Symptom Burden

    Time frame: 3 weeks

    Study personnel will administer questionnaire

Secondary outcomes

  1. Formula Intake

    Time frame: 24 hours

    Caregivers will document on diary records

  2. Fussiness

    Time frame: 24 hours

    Caregivers will document on diary records

  3. Formula Satisfaction Questionnaire

    Time frame: 3 weeks

    Study personnel will administer questionnaire

  4. Adverse Events

    Time frame: 24 hours and 3 weeks

    Assessed throughout study

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2018
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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