The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
Status
Terminated
Conditions
Metabolomics
Treatments
Other: Experimental 1: Cow milk-based infant formula
Other: Control: Cow milk-based infant formula
Other: Experimental 2: Cow milk-based infant formula
Other: Experimental 3: Cow milk-based infant formula
Details and patient eligibility
About
The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
Enrollment
2 patients
Sex
All
Ages
10 to 14 days old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Singleton, 10-14 days of age at registration/randomization
- Term infant with birth weight of 2500 grams or more from a vaginal birth
- Formula feeding infants must be on formula for at least 3 days
- Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
- Signed informed consent
Exclusion criteria
- History of underlying metabolic or chronic disease or immune compromised
- Feeding difficulties or formula intolerance
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
2 participants in 5 patient groups
Control: Cow milk-based infant formula
Active Comparator group
Description:
Cow milk-based infant formula
Treatment:
Other: Control: Cow milk-based infant formula
Experimental 1: Cow milk-based infant formula
Experimental group
Description:
Cow milk-based infant formula with prebiotics
Treatment:
Other: Experimental 1: Cow milk-based infant formula
Experimental 2: Cow milk-based infant formula
Experimental group
Description:
Cow milk-based infant formula with probiotics
Treatment:
Other: Experimental 2: Cow milk-based infant formula
Experimental 3: Cow milk-based infant formula
Experimental group
Description:
Cow milk-based infant formula with prebiotics and probiotics
Treatment:
Other: Experimental 3: Cow milk-based infant formula
Human Milk Reference
No Intervention group
Description:
Human Milk Reference
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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