Tolerance of Healthy Term Infants Fed Infant Formulas #4

Abbott

Status and phase: Completed; Phase 3

Conditions: Healthy Term Infants

Treatments: Other: Hydrolysate based infant formula; Other: Investigational Infant Formula B; Other: Investigational Infant Formula A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01155414

AK75

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 1 to 8 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 3 patient groups

Investigational infant formula A

Experimental group

Description:

Investigational Protein Hydrolysate formula

Treatment:

Other: Investigational Infant Formula A

Hydrolysate based Infant Formula

Active Comparator group

Treatment:

Other: Hydrolysate based infant formula

Investigational Infant Formula B

Experimental group

Description:

Investigational Protein Hydrolysate Formula

Treatment:

Other: Investigational Infant Formula B