Skip to main content
OpenTrials
Completed

NCT Number: NCT02401217

Tolerance of Healthy Infants Fed Infant Formulas

The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Tolerance

Age range

Up to 30 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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton from a full term birth with a gestational age of 37-42 weeks.
  • Birth weight was > 2490 g (~5 lbs 8 oz).
  • Age between 0 and 30 days at enrollment.
  • Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
  • Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
  • Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
  • Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) 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 infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant treated with antibiotics.
  • Participation in another study that has not been approved as a concomitant study by AN.

Treatment and study plan

Phase 1- Arm 1 Infant Formula

Other

Powder infant formula

Phase 2- Arm 2 Infant Formula

Other

Powder infant formula

Phase 2- Arm 3 Infant Formula

Other

Powder infant formula

Primary outcomes

  1. Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries

    Time frame: Change from Study Day 1 to Study Day 15

    MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.

Secondary outcomes

  1. Mean Percentage of stools representing each stool consistency and color using parent reported diaries

    Time frame: Change from Study Day 1 to Study Day 15

    Mean percentage of each recorded stool consistency (watery, loose/mushy, soft, formed, hard) and stool color (yellow, brown, green, black) will be calculated for each infant and then used to calculate for each group from daily data recorded on daily stool records during the study.

  2. Mean predominant stool consistency and color measured using parent reported diaries

    Time frame: Change from Study Day 1 to Study Day 15

    Mean predominant stool consistency and color for each infant calculated from data recorded on daily stool records during the study will be used to calculate the mean predominant stool consistency and color for each group.

  3. Average number of stools per day measured using parent reported diaries

    Time frame: Change from Study Day 1 to Study Day 15

    Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study.

  4. Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.

    Time frame: Change from Study Day 1 to Study Day 15

    Mean percentages of feedings associated with spit-up and/or vomiting will be calculated for each group from data recorded on daily formula intake records during the study.

  5. Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires

    Time frame: Change from Study Day 1 to Study Day 15

    Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15

  6. Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.

    Time frame: Change from Study Day 1 to Study Day 15

    Parental responses to individual question on the Feeding and Stool Patterns Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15.

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Jan 12, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.