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OpenTrials
Completed

NCT Number: NCT01897922

The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.

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Key information

Conditions

Growth of Term Infants

Age range

12 day–16 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Pediatric Associates, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Singleton, 12-16 days of age at randomization
  • Term infant with birth weight of a minimum of 2500 grams
  • Solely formula fed
  • Signed Informed Consent and Protected Health Information

Exclusion criteria

  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or formula intolerance

Treatment and study plan

An investigational infant formula containing a probiotic source

Other

Control: Marketed routine infant formula

Other

Primary outcomes

  1. Body weight measured at each study visit

    Time frame: 3.5 months

Secondary outcomes

  1. Recall of infant formula intake at each study visit

    Time frame: 3.5 months

  2. Body length measured at each study visit

    Time frame: 3.5 months

  3. Recall of stool consistency measured at each study visit

    Time frame: 3.5 months

  4. Medically-confirmed adverse events collected throughout the study period

    Time frame: 3.5 months

  5. Parental Study Product Assessment Questionnaire completed at Study Visit 2

    Time frame: once

  6. Head circumference measured at each study visit

    Time frame: 3.5 months

  7. Recall of gastrointestinal tolerance measured at each study visit

    Time frame: 3.5 months

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Sep 25, 2015

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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