NCT07867509

Brief Summary

The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant formula. The key secondary outcome is to study sIgA levels from faecal samples at endline while controlling for baseline levels. Parents of the enrolled infants will be asked to complete a diary, let their infant undergo physical examinations and complete questionnaire and feed their infant the assigned infant formula

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
387

participants targeted

Target at P50-P75 for phase_3

Timeline
23mo left

Started Jan 2027

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

1.9 years

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Infant ALL

Keywords

infant formulainfantsgrowthimmune parameters

Outcome Measures

Primary Outcomes (1)

  • Growth

    weight gain per day

    12 weeks

Study Arms (3)

Intervention

EXPERIMENTAL

Infant formula with additional beneficial ingredients

Combination Product: Infant Formula

Control

ACTIVE COMPARATOR

infant formula without additional beneficial ingredients

Combination Product: Infant Formula

Reference

OTHER

Breastfeeding

Combination Product: Breastfeeding

Interventions

Infant FormulaCOMBINATION_PRODUCT

the experimental formula contains milk fat, MFGM, Lactoferrin, GOS and 2'FL

Intervention
BreastfeedingCOMBINATION_PRODUCT

Exclusively breastfeeding

Reference

Eligibility Criteria

AgeUp to 21 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full-term infants (born between gestational age ≥ 37 weeks\[Lv45.1\] - 42 weeks).
  • Healthy birthweight (according to WHO Child Growth Standards): 2500 g ≤ birthweight ≤ 4200 g (corresponding to Z-scores between the range of -2 SD and +2 SD)
  • Boys and girls
  • Apparently healthy at birth and screening
  • Weight-for-age Z-score (WAZ) at screening within the healthy range according to WHO Child Growth Standards (i.e. -2 SD ≤WAZ≤ 2SD)
  • Age at enrolment: ≤21 days of age\[Lv46.1\]
  • For breastfed group: exclusively breastfeeding infant and the intention to keep exclusively breastfeeding during study period
  • Being available for follow up during the duration of the study
  • Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years
  • Intention to exclusively feed infant milk (formula or human milk). No weaning during study period.

You may not qualify if:

  • 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 study outcomes (e.g. GI disorders, growth, immune-related diseases)
  • 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 sole source of nutrition for their child until the end of the study period
  • Past use of supplementation with probiotic supplements (e.g. Biogaia ProTectis Baby Drops, ProBiovit, Intermed Biolact) or infant formula containing probiotics or any specialties IFT \[(partially) hydrolysates, comfort formula, etc.\]
  • Antibiotic use in the first month of life (except exposure resulting from maternal peripartum antibiotic administration, which will be recorded)
  • Multiple gestation (e.g. twins, triplets or higher-order multiple births)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Infant FormulaLactation

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and BeveragesReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 9, 2026

Record last verified: 2026-10