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Completed

NCT Number: NCT00798382

Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

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Key information

Conditions

Infant, Newborn

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, 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

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
  • Infant's birth weight was > 2490 g (~5 lb 8 oz).
  • Infant is between 0 and 8 days of age at enrollment.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
  • Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

Exclusion criteria

  • An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant has been treated with antibiotics.
  • Infant has received probiotics.

Treatment and study plan

soy protein formula

Other

ad lib for 0-35 days of age

Other names: experimental soy formula

Commercially available soy formula

Other

ad lib for 0-35 days of age

Soy formula experimental #2

Other

ad lib for 0-35 days of age

Other names: Experimental soy formula

Primary outcomes

  1. Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.

    Time frame: 35 days

Secondary outcomes

  1. Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age

    Time frame: 35 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 26, 2008
Registry last updated
Jun 14, 2012

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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