Tolerance of Healthy Term Infants Fed Infant Formulas #3

Abbott

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Tolerance

Treatments: Other: Experimental milk protein infant formula Process C; Other: Experimental milk protein infant formula Process A; Other: Experimental milk protein infant formula Process E; Other: Experimental milk protein infant formula Process F; Other: Experimental milk protein infant formula Process D; Other: Experimental milk protein infant formula Process B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977964

AK70

Details and patient eligibility

About

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Enrollment: 270 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.
• Infant's birth weight was > 2490 g (~5 lbs 8 oz.
• Infant is between 0 and 8 days of age at enrollment.
• Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
• 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, unless instructed otherwise by their healthcare professional.

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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270 participants in 6 patient groups

Milk Based Protein Formula Process A

Experimental group

Treatment:

Other: Experimental milk protein infant formula Process A

Milk Based Protein Formula Process B

Experimental group

Treatment:

Other: Experimental milk protein infant formula Process B

Milk Based Protein Formula Process C

Experimental group

Treatment:

Other: Experimental milk protein infant formula Process C

Milk Based Protein Formula Process D

Experimental group

Treatment:

Other: Experimental milk protein infant formula Process D

Milk Based Protein Formula Process E

Experimental group

Treatment:

Other: Experimental milk protein infant formula Process E

Milk Based Protein Formula Process F

Experimental group

Treatment:

Other: Experimental milk protein infant formula Process F