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OpenTrials
Completed

NCT Number: NCT03307122

Gastrointestinal Tolerance Evaluation of an Infant Formula

Prospective, double-blind, randomized study of 2 infant formulas.

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Key information

Age range

9 day–19 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avanza Medical Research Center, Pensacola, Florida, United States

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About this study

Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy newborn singleton infant
  • Full-term (> 37 weeks gestation)
  • Birth weight ≥ 2500 grams and ≤ 4500 grams
  • 9-19 days of age on enrollment
  • Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
  • 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. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
  • Currently not tolerating (as perceived by the caregiver) their formula
  • Currently being treated for reflux
  • Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going 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 prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
  • 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 1

Other

Routine infant formula with probiotic

Routine Infant Formula 2

Other

Routine infant formula with probiotic and prebiotic

Primary outcomes

  1. Infant GI Symptom Burden

    Time frame: 6 weeks

    Study personnel will administer questionnaire

Secondary outcomes

  1. Stool pattern

    Time frame: 6 weeks

    Caregivers will document on diary records

  2. Spit-up and/or vomiting pattern

    Time frame: 6 weeks

    Caregivers will document on diary records

  3. Crying and fussing duration

    Time frame: 6 weeks

    Caregivers will document on diary records

  4. Formula intake

    Time frame: 6 weeks

    Caregivers will document on diary records

  5. Formula satisfaction questionnaire

    Time frame: 6 weeks

    Study personnel will administer questionnaire

  6. Weight (measured in grams)

    Time frame: Enrollment and 6 weeks

    Study personnel will measure

  7. Length (measured in centimeters)

    Time frame: Enrollment and 6 weeks

    Study personnel will measure

  8. Adverse events

    Time frame: 2 weeks and 6 weeks

    Assessed throughout study

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Infant Formula GI Tolerance Evaluation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2017
Registry last updated
May 23, 2018

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.