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OpenTrials
Completed

NCT Number: NCT02757924

Behavior of Infants Fed Formula Supplemented With Prebiotics

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

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Key information

Age range

7 day–42 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southeastern Pediatric Associates, Dothan, 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

  • Subject is judged to be in good health.
  • Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
  • Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
  • Infant was identified by parents as very fussy or extremely fussy.
  • Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product 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

  • An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
  • Subject participates in another study that has not been approved as a concomitant study.
  • Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
  • Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
  • Mother intends to use a combination of breast and formula feeding.

Treatment and study plan

Infant formula supplemented with prebiotics

Other

Sole source nutrition

Primary outcomes

  1. Fussiness

    Time frame: Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding

    Parent questionnaires

Secondary outcomes

  1. Fussiness

    Time frame: Baseline to Day 29

    Parent Questionnaires

  2. Hours of Daily Crying

    Time frame: Baseline to Day 29

    Parent Questionnaires

  3. Gastrointestinal Tolerance

    Time frame: Baseline to Day 29

    Parent Questionnaires

  4. Stool Pattern

    Time frame: Baseline to Day 29

    Parent Questionnaires

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2016
Registry last updated
Jun 19, 2017

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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