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OpenTrials
Completed

NCT Number: NCT00543673

Tolerance of Healthy, Term Infants to Infant Formulas

To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Completed

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Key information

Conditions

Healthy

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Pediatric Clinic, North 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

  • judged to be in good health.
  • singleton from a full term birth with a gestational age of 37-42 weeks
  • birth weight was > 2490 g (~5 lbs 8 oz)
  • between 0 and 8 days of age at enrollment.
  • Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion criteria

  • An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
  • Infant has been treated with antibiotics.

Treatment and study plan

Milk based formula A

Other

feed as per HCP directions

Other names: AN0710A

#2 Standard formula

Other

Feed as per HCP directions

Other names: AN0710B

#3 Human Milk

Other

Feed as per HCP directions

Other names: Human Milk

Milk based formula C

Other

Feed as per HCP direction

Other names: AN0710C

Primary outcomes

  1. Mean rank stool consistency (MRSC)

    Time frame: Study Day 1 to Visit 3

Secondary outcomes

  1. MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2007
Registry last updated
Jul 4, 2008

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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