Tolerance of Healthy Term Infants Fed Infant Formulas
Status and phase
Completed
Phase 2
Conditions
Infant, Newborn
Treatments
Other: milk protein formulas, varying carbohydrate/protein sources
Details and patient eligibility
About
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
Enrollment
190 patients
Sex
All
Ages
Under 8 days old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age
Exclusion criteria
- medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
190 participants in 5 patient groups
1
Experimental group
Description:
Experimental milk protein based infant formula with varying carbohydrate and protein source
Treatment:
Other: milk protein formulas, varying carbohydrate/protein sources
2
Experimental group
Description:
Experimental milk protein based infant formula with varying carbohydrate and protein source
Treatment:
Other: milk protein formulas, varying carbohydrate/protein sources
3
Experimental group
Description:
Experimental milk protein based infant formula with varying carbohydrate and protein source
Treatment:
Other: milk protein formulas, varying carbohydrate/protein sources
4
Experimental group
Description:
Experimental milk protein based infant formula with varying carbohydrate and protein source
Treatment:
Other: milk protein formulas, varying carbohydrate/protein sources
5
Experimental group
Description:
Experimental milk protein based infant formula with varying carbohydrate and protein source
Treatment:
Other: milk protein formulas, varying carbohydrate/protein sources
Trial contacts and locations
15
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Data sourced from clinicaltrials.gov
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