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

Last updated: March 26, 2024
Sponsor: FrieslandCampina
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

standard cows milk infant formula and follow-on formula

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

Clinical Study ID

NCT06137235
Armadillo
  • Ages 5-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 WHOChild Growth Standards
  • Age at enrolment: ≤60 days of age
  • If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 daysprior to inclusion
  • If 1 month < age at inclusion ≤ 2 months: infants exclusively formula fed since 1month 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

Exclusion Criteria:

  • Severe acquired or congenital diseases, mental or physical disorders, including cow'smilk protein allergy (CMA), lactose intolerance and diagnosed medical conditions thatare 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 fortheir 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 Design

Total Participants: 456
Treatment Group(s): 2
Primary Treatment: standard cows milk infant formula and follow-on formula
Phase:
Study Start date:
December 18, 2023
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Harokopio University

    Athens,
    Greece

    Active - Recruiting

  • International Hellenic University

    Thessaloníki,
    Greece

    Active - Recruiting

  • University of Thessaly

    Tríkala,
    Greece

    Active - Recruiting

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