Tolerance of Healthy Infants Fed Infant Formulas

Abbott Nutrition126 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

126

Conditions

Gastrointestinal Tolerance

Interventions

Phase 1- Arm 1 Infant FormulaOTHER

Powder infant formula

Phase 2- Arm 2 Infant FormulaOTHER

Powder infant formula

Phase 2- Arm 3 Infant FormulaOTHER

Powder infant formula

Eligibility

Sex: ALLMax age: 30 Days

Medical Language ↔ Plain English

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.

Locations (6)

W.O.M.B Watching Over Mothers and Babies

Tucson, Arizona, United States

SCORE Physician Alliance LLC

St. Petersburg, Florida, United States

White Oak Family Physicians DBA/Asheboro Research Associates

Asheboro, North Carolina, United States

Institute of Clinical Research, LLC

Mayfield Heights, Ohio, United States

Outcomes

Primary Outcomes

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.