Gastrointestinal Tolerance of Infant Formula

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Reference Group; Other: Experimental 1 Infant Formula; Other: Experimental 2 Infant Formula

• Registration Number: NCT02322138
• Lead Sponsor: Abbott Nutrition

Brief Summary

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Infant is judged to be in good health.
• Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
• Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
• Infant is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
• 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

• Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
• Mother intends to use a combination of breast and formula feeding.
• 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
Human Milk-Fed Reference Group	Reference Group	Breast fed infants
Experimental 1 Infant Formula	Experimental 1 Infant Formula	Milk-based infant formula without prebiotics
Experimental 2 Infant Formula	Experimental 2 Infant Formula	Milk-based infant formula with prebiotics

Primary Outcome Measures

Name	Time	Method
Stool Consistency Questionnaire	Baseline to 35 Days of Age	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Head Circumference	Baseline to 35 Days of Age	Measured
Length	Baseline to 35 Days of Age	Measured
Stools per Day Questionnaire	Baseline to 35 Days of Age	Questionnaire
Feeding Spit Up Questionnaire	Baseline to 35 Days of Age	Questionnaire
Weight	Baseline to 35 Days of Age	Measured

Trial Locations

Locations (10)

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

Norwich Pediatric Group, PC; 🇺🇸 Norwich, Connecticut, United States

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

Clinical Research Advantage/Colorado Springs Health Partners; 🇺🇸 Colorado Springs, Colorado, United States

Michael W. Simon, M.D., PSC; 🇺🇸 Nicholasville, Kentucky, United States

Women's Clinic of Lincoln, PC.; 🇺🇸 Lincoln, Nebraska, United States

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

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

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

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