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Completed

NCT Number: NCT03967132

Growth and Tolerance of Infants Fed Milk-Based Infant Formula

The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

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Key information

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Watching Over Mothers & 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

  • Good health as determined from participant's medical history
  • Singleton from a full-term birth with a gestational age of 37-42 weeks
  • Birth weight was > 2490 g (~5 lbs. 8 oz.)
  • If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
  • If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7.
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
  • Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion criteria

  • An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
  • Participant participates in another study that has not been approved as a concomitant study by AN.

Treatment and study plan

Control infant formula

Other

Ready to feed infant formula, feed ad libitum

Experimental Infant Formula

Other

Ready to feed infant formula, feed ad libitum

Reference Group

Other

Human milk, breast feeding ad libitum

Primary outcomes

  1. Weight

    Time frame: Day of life 14 - 119

    Weight gain per day

Secondary outcomes

  1. Stool Characteristics

    Time frame: Study Day 1 to Day of life 119

    Parent completed diary

  2. Formula Tolerance

    Time frame: Study Day 1 to Day of life 119

    Parent completed diary

  3. Length

    Time frame: Study Day 1 to Day of life 119

    Length gain per day

  4. Head Circumference (HC)

    Time frame: Study Day 1 to Day of life 119

    HC gain per day

  5. Illness Incidence

    Time frame: Study Day 1 to Day of life 119

    Parent reported incidence of illness

Other outcomes

  1. Stool Sample

    Time frame: Study Day 1 to Day of life 119

    Microbiota characterization

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 30, 2019
Registry last updated
Sep 22, 2020

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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