Acceptance Of A Partially-Hydrolyzed Infant Formula

Mead Johnson Nutrition

Status: Completed

Conditions: Stool

Treatments: Other: Control; Other: Investigational

Study type: Interventional

Funder types: Industry

Identifiers

NCT03223792

3389-1

Details and patient eligibility

About

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Enrollment: 100 patients

Sex: All

Ages: 28 to 300 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton 28-300 days of age at randomization
• Gestational age less than or equal to 35 weeks
• Receiving minimum 18oz infant formula in the 24hrs prior to randomization
• History of hard stools or stooling difficulty
• Signed informed consent and protected health information

Exclusion criteria

• Current diagnosis of cow's milk protein allergy or intolerance
• Use of extensively hydrolyzed or amino acid formula at randomization
• Any abdominal or gastrointestinal surgery prior to randomization
• History of underlying metabolic or chronic disease or congenital malformation
• Organic causes of constipation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Other: Control

Investigational

Experimental group

Treatment:

Other: Investigational