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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Phase 1- Arm 1 Infant Formula; Other: Phase 2- Arm 2 Infant Formula; Other: Phase 2- Arm 3 Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • W.O.M.B Watching Over Mothers and Babies
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance LLC
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • White Oak Family Physicians DBA/Asheboro Research Associates
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Memorial Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1-Arm 1 Infant Formula; Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum.	Other: Phase 1- Arm 1 Infant Formula; Powder infant formula
Active Comparator: Phase 2- Arm 2 Infant Formula; Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum.	Other: Phase 2- Arm 2 Infant Formula; Powder infant formula
Experimental: Phase 2- Arm 3 Infant Formula; Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum.	Other: Phase 2- Arm 3 Infant Formula; Powder infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries	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.	Change from Study Day 1 to Study Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage of stools representing each stool consistency and color using parent reported diaries	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.	Change from Study Day 1 to Study Day 15
Mean predominant stool consistency and color measured using parent reported diaries	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.	Change from Study Day 1 to Study Day 15
Average number of stools per day measured using parent reported diaries	Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study.	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.	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.	Change from Study Day 1 to Study Day 15
Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires	Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15	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.	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.	Change from Study Day 1 to Study Day 15

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: AL12