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Completed

NCT Number: NCT01155414

Tolerance of Healthy Term Infants Fed Infant Formulas #4

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

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Key information

Conditions

Healthy Term Infants

Age range

1 day–8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, 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

  • Singleton full term birth in good health
  • Birth weight was > 2490 g.
  • Between 0 and 8 days of age.
  • Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to 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, unless instructed otherwise by their healthcare professional.
  • 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.

Exclusion criteria

  • An adverse maternal, fetal or infant medical history and treatment with antibiotics

Treatment and study plan

Hydrolysate based infant formula

Other

Infant formula ad lib

Investigational Infant Formula A

Other

Investigational infant formula ad lib

Investigational Infant Formula B

Other

Investigational infant formula ad lib

Primary outcomes

  1. GI tolerance via stool consistency

    Time frame: 28 days

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
2010
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2010
Registry last updated
Nov 1, 2011

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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