Growth and Tolerance Trial on Infant Formula With HMO (Stardust)

FrieslandCampina

Status: Terminated

Conditions: Healthy Growth

Treatments: Other: Standard infant formula; Other: Infant formula supplemented with HMO

Study type: Interventional

Funder types: Industry

Identifiers

NCT04066413

Stardust

Details and patient eligibility

About

The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.

Enrollment: 265 patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational age ≥ 37 weeks
• Birth weight ≥ 2500 grams
• No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
• Boys and girls
• Recruited < 1 month/age
• Being available for follow up until the age of 4 months
• Exclusive formula feeding or exclusive breast feeding at time of recruitment

Exclusion criteria

• Gestational age <37 weeks
• Birth weight <2500 grams
• Severe acquired or congenital diseases, mental or physical disorders
• Illness at screening/ inclusion
• Incapability of parents/caregivers to comply with the study protocol
• Received antibiotics within the first month of life
• Not tolerating standard cow's milk based infant formula
• Participation in another clinical trial
• Maternal illicit drug use during pregnancy or post-partum period
• Parent/caregiver does not have a cell phone to use for filling out questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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265 participants in 3 patient groups, including a placebo group

Breastfed group

No Intervention group

Description:

Non-randomized breastfed reference group

Control formula

Placebo Comparator group

Description:

Group receiving standard infant formula

Treatment:

Other: Standard infant formula

Formula with HMO

Active Comparator group

Description:

Group receiving standard infant formula supplemented with HMO

Treatment:

Other: Infant formula supplemented with HMO