Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections

March 26, 2024 updated by: FrieslandCampina

A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants

In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included <2mo of age.

Study Type

Interventional

Enrollment (Estimated)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • Harokopio University
        • Contact:
      • Thessaloníki, Greece
        • Recruiting
        • International Hellenic University
        • Contact:
      • Tríkala, Greece
        • Recruiting
        • University of Thessaly
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Full-term infants
  • Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g
  • Boys and girls
  • Apparently healthy at birth and screening
  • Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards
  • Age at enrolment: ≤60 days of age
  • If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion
  • If 1 month < age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2
  • Being available for follow up until the age of 12 months
  • Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years

Exclusion Criteria:

  • Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))
  • 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 until the age of 12 months
  • Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test formula
infant formula and follow-on formula with bioactive ingredients
Other: cows milk infant formula and follow-on formula with bioactive ingredients
infant formula and follow-on formula with bioactive ingredients
Active Comparator: control formula
standard infant formula and follow-on formula
Other: standard cows milk infant formula and follow-on formula
standard cows milk infant formula and follow-on formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: until age of 6 months
weight for age, compared to WHO growth curve, for test group only
until age of 6 months
infection-related morbidity episodes, parent-reported
Time Frame: 6 - 12 months of age
number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group
6 - 12 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: until the age of 6 months
weight for age, compared to WHO growth curve, for control group
until the age of 6 months
length
Time Frame: until the age of 6 months
length in cm
until the age of 6 months
head circumference
Time Frame: until the age of 6 months
head circumference in cm
until the age of 6 months
BMI
Time Frame: until the age of 6 months
BMI in kg/m2
until the age of 6 months
product tolerance: GI comfort
Time Frame: until the age of 6 months
GI comfort questionnaire
until the age of 6 months
product tolerance: stool frequency and consistency
Time Frame: until the age of 6 months
stool frequency and consistency questionnaire
until the age of 6 months
product tolerance: product intake
Time Frame: until the age of 6 months
product intake (ml/feeding, ml/day)
until the age of 6 months
Duration of infection-related episodes
Time Frame: 6 - 12 months of age
duration of parental-reported respiratory and gut infection-related symptoms in summed days
6 - 12 months of age
infection-related morbidity episodes, physician-diagnosed
Time Frame: 6 - 12 months of age
number of physician-diagnosed respiratory and gut infection-related symptoms
6 - 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FrieslandCampina

Investigators

  • Principal Investigator: Yannis Manios, Prof, Harokopio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Armadillo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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