Efficacy of a New Infant Formula Composition on Gut Health in Infants
NCT ID: NCT07242508
Last Updated: 2025-11-21
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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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-11-25
2026-08-19
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
OTHER
QUADRUPLE
Study Groups
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Experimental infant formula
Infant formula with bioactive ingredients
Infant Formula with bioactive ingredients
ad-libitum consumption
Control formula
Standard infant formula
Infant Formula
ad-libitum consumption of infant formula
Interventions
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Infant Formula
ad-libitum consumption of infant formula
Infant Formula with bioactive ingredients
ad-libitum consumption
Eligibility Criteria
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Inclusion Criteria
* Parents independently from study decided to not breastfeed their infant
* Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
* have read and voluntarily signed an informed consent form
* parents are capable of completing study procedures required by the protocol
Exclusion Criteria
* are required to take medications or supplements known to influence growth and development
* have a maternal history with known adverse effects on the fetus and/or the newborn infant
* have previous or current antibiotics use (antibiotics administered during delivery are permitted)
* have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
* personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance
* multiple birth
* participation in another trial
0 Days
3 Days
ALL
Yes
Sponsors
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FrieslandCampina
INDUSTRY
Responsible Party
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Other Identifiers
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ECCT2831
Identifier Type: -
Identifier Source: org_study_id
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