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Completed

NCT Number: NCT02322138

Gastrointestinal Tolerance of Infant Formula

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

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Key information

Conditions

Gastrointestinal Tolerance

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

W.O.M.B Watching Over Mothers and Babies, Tucson, Arizona, 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 lbs 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 (formula-fed infants) or human milk (human milk-fed infants) 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 from enrollment through the duration of the study.

Exclusion criteria

  • Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
  • Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
  • Mother intends to use a combination of breast and formula feeding.
  • Participation in another study that has not been approved as a concomitant study by AN.

Treatment and study plan

Experimental 1 Infant Formula

Other

Ready to feed infant formula to be fed ad-libitum

Experimental 2 Infant Formula

Other

Ready to feed infant formula to be fed ad-libitum

Reference Group

Other

Breast fed ad libitum

Primary outcomes

  1. Stool Consistency Questionnaire

    Time frame: Baseline to 35 Days of Age

    Questionnaire

Secondary outcomes

  1. Stools per Day Questionnaire

    Time frame: Baseline to 35 Days of Age

    Questionnaire

  2. Feeding Spit Up Questionnaire

    Time frame: Baseline to 35 Days of Age

    Questionnaire

  3. Weight

    Time frame: Baseline to 35 Days of Age

    Measured

  4. Length

    Time frame: Baseline to 35 Days of Age

    Measured

  5. Head Circumference

    Time frame: Baseline to 35 Days of Age

    Measured

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Gastrointestinal Tolerance of Formula Supplemented With Prebiotics

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2014
Registry last updated
Jul 23, 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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