Tolerance of Healthy Infants Fed Infant Formulas

Abbott Nutrition6 sites in 1 country126 target enrollmentApril 2015

ConditionsGastrointestinal Tolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Tolerance
Sponsor: Abbott Nutrition
Enrollment: 126
Locations: 6
Primary Endpoint: Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Mean predominant stool consistency and color measured using parent reported diaries(Change from Study Day 1 to Study Day 15)
Average number of stools per day measured using parent reported diaries(Change from Study Day 1 to Study Day 15)
Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.(Change from Study Day 1 to Study Day 15)
Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.(Change from Study Day 1 to Study Day 15)
Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires(Change from Study Day 1 to Study Day 15)
Mean Percentage of stools representing each stool consistency and color using parent reported diaries(Change from Study Day 1 to Study Day 15)