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

November 17, 2025 updated by: FrieslandCampina

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

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:

  • 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

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: Experimental infant formula
Infant formula with bioactive ingredients
Other: Infant Formula with bioactive ingredients
ad-libitum consumption
Placebo Comparator: Control formula
Standard infant formula
Other: Infant Formula
ad-libitum consumption of infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bifidobacterium
Time Frame: From enrollment to the end of treatment at 10 weeks
Relative abundance of bifidobacterium from stool samples
From enrollment to the end of treatment at 10 weeks

Collaborators and Investigators

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

Sponsor

FrieslandCampina

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 (Estimated)

November 25, 2025

Primary Completion (Estimated)

August 19, 2026

Study Completion (Estimated)

August 19, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECCT2831

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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