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OpenTrials
Completed

NCT Number: NCT02456805

Alternate Formula Feedings in Formula Intolerant Infants

This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.

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Key information

Conditions

Gastrointestinal Tolerance

Age range

2 week–9 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optimum Clinical Research, Oshawa, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
  • Infants whose physicians had made a recommendation that the parents change the infant's feeding.
  • Full term infants at birth with a gestational age of 37 to 42 weeks.
  • Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion criteria

  • Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
  • Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.

Treatment and study plan

Infant Formula 1

Other

Feed ab libitum

Infant Formula 2

Other

Feed ab libitum

Primary outcomes

  1. Stool Characteristics

    Time frame: Change from Baseline (Study Day 1) to Study Day 15

    Parent questionnaire

Secondary outcomes

  1. Formula Intake

    Time frame: Change from Baseline (Study Day 1) to Study Day 15

    Parent questionnaire on volume consumed

  2. Incidence of spit up/vomiting

    Time frame: Change from Baseline (Study Day 1) to Study Day 15

    Parent questionnaire

  3. Weight

    Time frame: Change from Baseline (Study Day 1) to Study Day 15

    Measured weight at visits

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Efficacy of Alternate Formula Feedings in Formula Intolerant Infants

Important dates

Study start
1996
Primary completion
1997
Study completion
1997
First posted
May 29, 2015
Registry last updated
May 29, 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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