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

NCT07242508 | Not Yet Recruiting

• 1 other identifier: ECCT2831
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Infants

Keywords

infant; formula; microbiota; gut health; RCT

Outcome Measures

Primary Outcomes (1)

• Bifidobacterium

  Relative abundance of bifidobacterium from stool samples

  From enrollment to the end of treatment at 10 weeks

Study Arms (2)

Experimental infant formula

EXPERIMENTAL

Infant formula with bioactive ingredients

Other: Infant Formula with bioactive ingredients

Control formula

PLACEBO COMPARATOR

Standard infant formula

Other: Infant Formula

Interventions

Infant Formula OTHER

ad-libitum consumption of infant formula

Control formula

Infant Formula with bioactive ingredients OTHER

ad-libitum consumption

Experimental infant formula

Eligibility Criteria

• Age: 0 Days - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FrieslandCampina: lead

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

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 17, 2025
• First Posted: November 21, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share