The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-06

Study Completion Date

2022-10-24

Brief Summary

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In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.

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Detailed Description

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In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.

Conditions

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Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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test formula

hydrolysed protein-based infant formula

Group Type EXPERIMENTAL

infant formula based on hydrolyzed protein

Intervention Type OTHER

infant formula based on hydrolysed protein

control formula

standard intact protein-based formula

Group Type ACTIVE_COMPARATOR

infant formula based on intact protein

Intervention Type OTHER

infant formula based on intact protein

Interventions

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infant formula based on hydrolyzed protein

infant formula based on hydrolysed protein

Intervention Type OTHER

infant formula based on intact protein

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Full-term infants (born at gestational age =37 weeks).
* Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
* Boys and girls
* Apparently healthy at birth and screening
* Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
* Age at enrolment: =28 days of age
* Exclusively formula fed for at least 5 days prior to inclusion
* Exclusively formula fed during the entire intervention period
* Parents agreeing to initiate complementary feeding after finalization of the study
* Being available for follow up until the age of approximately 3.5 months
* Written informed consent from parent(s) and/or legal guardian(s) aged =18 years

Exclusion Criteria

* Gestational age \<37 weeks
* Birth weight \<2500 g or \>4200 g
* Age at enrolment: \>28 days
* Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
* Illness at screening/inclusion
* Incapability of parents to comply with the study protocol
* Illiterate parents (i.e. not able to read and write in local language)
* Participation in another clinical trial
* Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
* infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula

Minimum Eligible Age

5 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes