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Completed

NCT Number: NCT04529759

Healthy Term Infants Fed Milk-Based Infant Formula

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Completed

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Key information

Conditions

Tolerance

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visions Clinical Research, Tucson, Arizona, United States

Loading trial locations.

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.)
  • 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, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study
  • Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) 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 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 gastrointestinal (GI) tolerance
  • Participant is enrolled in another study that has not been approved as a concomitant study

Treatment and study plan

Control infant formula

Other

Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide

Experimental Infant Formula

Other

Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend

Primary outcomes

  1. Mean rank stool consistency (MRSC)

    Time frame: Study Day 1 to 28 Days of Age

    Parent Completed Diary

Secondary outcomes

  1. Weight

    Time frame: 14 to 119 Days of Age

    Interval weight gain per day

  2. Gastrointestinal tolerance

    Time frame: 14 to 119 Days of Age

    Parent Completed Diary

  3. Length

    Time frame: 14 to 119 Days of Age

    Interval length gain per day

  4. Head Circumference

    Time frame: 14 to 119 Days of Age

    Interval head circumference gain per day

Other outcomes

  1. Infant Stool Characteristics

    Time frame: Study Day 1 to 119 Days of Age

    Parent Completed Diary

  2. Study Product Intake

    Time frame: Study Day 1 to 119 Days of Age

    Parent Completed Diary

  3. Infant and Household Characteristics

    Time frame: Study Day 1 to 119 Days of Age

    Parent reported lifestyle and illness questions

  4. Health Resource Utilization

    Time frame: Study Day 1 to 119 Days of Age

    Number of Visits

  5. Infant Feeding and Stool Patterns Questionnaire

    Time frame: Exit or 119 Days of Age

    Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction

  6. Infant Behavior Questionnaire

    Time frame: Exit or 119 Days of Age

    Parent completed questionnaire; 22 questions with 5-point Likert scale questions; scaled in the negative direction

  7. Formula Satisfaction Questionnaire

    Time frame: Exit or 119 Days of Age

    Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction

  8. Adverse Events

    Time frame: Study Day 1 to 119 Days of Age

    Standard adverse event reporting

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2020
Registry last updated
Jul 15, 2021

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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