The Effects of an Infant Formula Containing Hydrolysed Pr... | NCT05757323

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

NCT05757323

Sponsor

FrieslandCampina

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

345Actual

Phase

Not Applicable

Conditions

Growth

Interventions

infant formula based on hydrolyzed protein
infant formula based on intact protein

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2021Actual

Primary Completion Date

Oct 24, 2022Actual

Completion Date

Oct 24, 2022Actual

First Submitted Date

Feb 24, 2023

First Submission Date that Met QC Criteria

Feb 24, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2023

Last Update Posted Date

Sep 22, 2023Actual

Description Module

Brief Summary

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

345Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test formula	Experimental	hydrolysed protein-based infant formula	Other: infant formula based on hydrolyzed protein
control formula	Active Comparator	standard intact protein-based formula	Other: infant formula based on intact protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
infant formula based on hydrolyzed protein	Other	infant formula based on hydrolysed protein	test formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight gain	weight gain in g/day	until 17 weeks of age

Secondary Outcomes

Measure	Description	Time Frame
Weight	Weight in g	until 17 weeks of age
Length	length in cm	until 17 weeks of age

Other Outcomes

Measure	Description	Time Frame
formula intake	formula intake in ml	until 17 weeks of age

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Days

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yannis Manios, Prof	Harokopio University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nutrition and Dietetics, University of Thessaly		Trikala	Thessaly	42132	Greece
Harokopio University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38827219	Derived	Kantaras P, Kokkinopoulou A, Hageman JHJ, Hassapidou M, Androutsos O, Kanaki M, Bovee-Oudenhoven I, Karaglani E, Kontochristopoulou AM, Bos R, Manios Y. Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial. Front Pediatr. 2024 May 17;12:1328709. doi: 10.3389/fped.2024.1328709. eCollection 2024.