NCT06137235

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

November 14, 2023

Last Update Submit

January 26, 2026

Conditions

GrowthInfections

Keywords

infant nutritiongrowthgut comfortproduct toleranceinfections

Outcome Measures

Primary Outcomes (2)

  • weight

    weight for age, compared to WHO growth curve, for test group only

    until age of 6 months

  • infection-related morbidity episodes, parent-reported

    number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group

    6 - 12 months of age

Secondary Outcomes (9)

  • weight

    until the age of 6 months

  • length

    until the age of 6 months

  • head circumference

    until the age of 6 months

  • BMI

    until the age of 6 months

  • product tolerance: GI comfort

    until the age of 6 months

  • +4 more secondary outcomes

Other Outcomes (6)

  • weight

    at the age of 2 and 3 years

  • length

    at the age of 2 and 3 years

  • head circumference

    at the age of 2 and 3 years

  • +3 more other outcomes

Study Arms (2)

test formula

EXPERIMENTAL

infant formula and follow-on formula with bioactive ingredients

Other: cows milk infant formula and follow-on formula with bioactive ingredients

control formula

ACTIVE COMPARATOR

standard infant formula and follow-on formula

Other: standard cows milk infant formula and follow-on formula

Interventions

standard cows milk infant formula and follow-on formulaOTHER

standard cows milk infant formula and follow-on formula

control formula
cows milk infant formula and follow-on formula with bioactive ingredientsOTHER

infant formula and follow-on formula with bioactive ingredients

test formula

Eligibility Criteria

Age5 Days - 60 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Harokopio University

Athens, Greece

Location

International Hellenic University

Thessaloniki, Greece

Location

University of Thessaly

Trikala, Greece

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Yannis Manios, Prof

    Harokopio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

December 18, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(3)