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NCT Number: NCT07242508

Efficacy of a New Infant Formula Composition on Gut Health in Infants

The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored

Recruiting

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Key information

Conditions

Healthy Infants

Age range

0 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, full term, infants with a birth weight between 2500-4500 grams
  • Parents independently from study decided to not breastfeed their infant
  • Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study
  • have read and voluntarily signed an informed consent form
  • parents are capable of completing study procedures required by the protocol

Exclusion criteria

  • suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding
  • are required to take medications or supplements known to influence growth and development
  • have a maternal history with known adverse effects on the fetus and/or the newborn infant
  • have previous or current antibiotics use (antibiotics administered during delivery are permitted)
  • have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)
  • personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance
  • multiple birth
  • participation in another trial

Treatment and study plan

Infant Formula

Other

ad-libitum consumption of infant formula

Infant Formula with bioactive ingredients

Other

ad-libitum consumption

Primary outcomes

  1. Bifidobacterium

    Time frame: From enrollment to the end of treatment at 10 weeks

    Relative abundance of bifidobacterium from stool samples

Sponsors and collaborators

Lead sponsor

FrieslandCampina

Industry

Registry information

Official study title

Efficacy of a New Infant Formula Composition on Gut Health in Infants: A Prospective Randomized Double-blind Placebo-controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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