Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
265 participants
INTERVENTIONAL
2019-09-23
2023-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Breastfed group
Non-randomized breastfed reference group
No interventions assigned to this group
Control formula
Group receiving standard infant formula
Standard infant formula
Standard infant formula
Formula with HMO
Group receiving standard infant formula supplemented with HMO
Infant formula supplemented with HMO
Infant formula supplemented with HMO
Interventions
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Standard infant formula
Standard infant formula
Infant formula supplemented with HMO
Infant formula supplemented with HMO
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
ALL
Yes
Sponsors
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FrieslandCampina
INDUSTRY
Responsible Party
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Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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Stardust
Identifier Type: -
Identifier Source: org_study_id
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