Tolerance of Healthy Term Infants Fed Infant Formulas #4

Phase 3

Completed

• Conditions: Healthy Term Infants
• Interventions: Other: Investigational Infant Formula A; Other: Hydrolysate based infant formula; Other: Investigational Infant Formula B

• Registration Number: NCT01155414
• Lead Sponsor: Abbott Nutrition

Brief Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Posted: 2010-07-01
• Status Verified: 2010-11
• Last Update Submitted: 2011-10-31
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Singleton full term birth in good health
• Birth weight was > 2490 g.
• Between 0 and 8 days of age.
• Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational infant formula A	Investigational Infant Formula A	Investigational Protein Hydrolysate formula
Hydrolysate based Infant Formula	Hydrolysate based infant formula	-
Investigational Infant Formula B	Investigational Infant Formula B	Investigational Protein Hydrolysate Formula

Primary Outcome Measures

Name	Time	Method
GI tolerance via stool consistency	28 days

Trial Locations

Locations (9)

University of Iowa; 🇺🇸 Coralville, Iowa, United States

Alabama Clinical Therapeutics, LLC; 🇺🇸 Dothan, Alabama, United States

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

Ohio Pediatric Research Association; 🇺🇸 Huber Heights, Ohio, United States

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

Medical Associates Clinic, PC; 🇺🇸 Dubuque, Iowa, United States

Pediatric Clinical Research Office; 🇺🇸 Hershey, Pennsylvania, United States

The Jackson Clinic, PA; 🇺🇸 Jackson, Tennessee, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States