Tolerance of Healthy Infants Fed Infant Formulas

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Phase 2- Arm 2 Infant Formula; Other: Phase 2- Arm 3 Infant Formula; Other: Phase 1- Arm 1 Infant Formula

• Registration Number: NCT02401217
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2- Arm 2 Infant Formula	Phase 2- Arm 2 Infant Formula	Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum.
Phase 2- Arm 3 Infant Formula	Phase 2- Arm 3 Infant Formula	Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum.
Phase 1-Arm 1 Infant Formula	Phase 1- Arm 1 Infant Formula	Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum.

Primary Outcome Measures

Name	Time	Method
Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries	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 Outcome Measures

Name	Time	Method
Mean predominant stool consistency and color measured using parent reported diaries	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.
Average number of stools per day measured using parent reported diaries	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.
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	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.
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	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.
Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires	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
Mean Percentage of stools representing each stool consistency and color using parent reported diaries	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.

Trial Locations

Locations (6)

W.O.M.B Watching Over Mothers and Babies; 🇺🇸 Tucson, Arizona, United States

White Oak Family Physicians DBA/Asheboro Research Associates; 🇺🇸 Asheboro, North Carolina, United States

SCORE Physician Alliance LLC; 🇺🇸 St. Petersburg, Florida, United States

Institute of Clinical Research, LLC; 🇺🇸 Mayfield Heights, Ohio, United States

The Cleveland Pediatric Research Center, LLC; 🇺🇸 Middleburg Heights, Ohio, United States

Tanner Memorial Clinic; 🇺🇸 Layton, Utah, United States