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Completed

NCT Number: NCT02456831

Soy Formula Feedings in Healthy, Term Infants

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

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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

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
  • Health infants reported to be tolerating a milk-based formula (Cohorts).
  • Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Treatment and study plan

Experimental Infant Formula 1

Other

method A phytate reduction and 5% protein hydrolysis

Experimental Infant Formula 2

Other

method A phytate reduction and 10% protein hydrolysis

Experimental Infant Formula 3

Other

method B phytate reduction and 5% protein hydrolysis

Active Comparator: Control Infant Formula

Other

Ready-to-Feed (RTF) Soy Infant Formula

Primary outcomes

  1. Stool Characteristics Questionnaire

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

    stool number, consistency, and color

Secondary outcomes

  1. Formula Intake

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

    volume consumed

  2. Gastrointestinal Tolerance Questionnaire

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

    Incidence of spit up and vomiting

  3. Weight

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

    weight and weight gain

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Efficacy of Soy Formula Feedings in Healthy, Term Infants

Important dates

Study start
1992
Primary completion
1994
Study completion
1994
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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