Growth and Tolerance of Healthy Term Infants to a New Infant Formula

Abbott

Status and phase: Terminated; Phase 3

Conditions: Healthy Term Infants

Treatments: Other: Investigational Infant Formula #1; Other: Human Milk; Other: Investigational Infant Formula #2; Other: Milk based infant formula powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137877

AK66

Details and patient eligibility

About

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

Enrollment: 399 patients

Sex: All

Ages: 1 to 11 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• in good health
• singleton full term birth
• Birth weight > 2490 g.
• Infant is between 0 and 11 days of age
• Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
• If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
• If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
• not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion criteria

adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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399 participants in 4 patient groups

Infant Formula #1

Active Comparator group

Description:

Milk-based Infant Formula Powder

Treatment:

Other: Milk based infant formula powder

Investigational Infant Formula #1

Experimental group

Description:

Investigational Milk-based Infant Formula Powder

Treatment:

Other: Investigational Infant Formula #1

Investigational Infant Formula #2

Experimental group

Description:

Investigational Milk based infant formula powder

Treatment:

Other: Investigational Infant Formula #2

Human Milk

Active Comparator group

Description:

Reference group

Treatment:

Other: Human Milk