Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infant, Newborn

Treatments: Other: Commercially available soy formula; Other: soy protein formula; Other: Soy formula experimental #2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798382

AK54

Details and patient eligibility

About

The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

Enrollment: 154 patients

Sex: All

Ages: Under 8 days old

Volunteers: Accepts Healthy Volunteers

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 lb 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 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 for the duration of the study.
• Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

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 has been treated with antibiotics.
• Infant has received probiotics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 3 patient groups

1: Soy formula

Experimental group

Description:

experimental soy formula #1

Treatment:

Other: soy protein formula

2: Soy Formula

Active Comparator group

Description:

Commercially available soy formula

Treatment:

Other: Commercially available soy formula

3: Soy formula

Experimental group

Description:

experimental soy formula #2

Treatment:

Other: Soy formula experimental #2