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Completed

NCT Number: NCT00977964

Tolerance of Healthy Term Infants Fed Infant Formulas #3

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

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Key information

Conditions

Gastrointestinal Tolerance

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, Dothan, 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

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth.
  • Infant's birth weight was > 2490 g (~5 lbs 8 oz.
  • Infant is between 0 and 8 days of age at enrollment.
  • Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.

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

Experimental milk protein infant formula Process A

Other

ad lib for 1-8 days of age until 28 days of age

Experimental milk protein infant formula Process B

Other

ad lib from 1-8 days of age until 28 days of age

Experimental milk protein infant formula Process C

Other

ad lib from 1-8 days of age to 28 days of age

Experimental milk protein infant formula Process D

Other

ad lib from 1-8 days of age until 28 days of age

Experimental milk protein infant formula Process E

Other

ad lib from 1-8 days of age until 28 days of age

Experimental milk protein infant formula Process F

Other

ad lib from 1-8 days of age until 28 days of age

Primary outcomes

  1. The primary variable is Gastrointestinal tolerance.

    Time frame: 1-28 days of age

Secondary outcomes

  1. The secondary variables are additional measures of GI tolerance and parental feedback.

    Time frame: 1-28 days of age

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Tolerance of Healthy Term Infants Fed Infant Formulas

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2009
Registry last updated
Nov 25, 2010

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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