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NCT07734532

Overview

NCT ID: NCT07734532
Lead Sponsor: Nutricia UK LtdINDUSTRY
Official Title: Gastrointestinal Tolerance, Safety And Acceptability In Infants Consuming Palm Oil Free Infant Formula Containing Prebiotics And Postbiotics
Brief Summary: This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period. Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition. The primary objective is to assess gastrointestinal tolerance and safety. Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome. The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Jul 29, 2026Actual
Start Date: Jun 17, 2021Actual
Primary Completion Date: Oct 18, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion criteria:

Parent's or legal guardian's aged 18 years, written informed consent.

Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention.

Infants aged 0 to 6 weeks (day 0 to day 42 inclusive).

Healthy term singleton infants, gestational age ~ 37 and < 42 weeks (i.e.,~ 41 weeks+ 6 days). Healthy is defined as no supervision or medical treatment by a medical specialist.

Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions).

Willing to continue using the infant formula, during the study, not switching of formula, except for medical purposes in which case the infant would be excluded.

Exclusion criteria:

Infants with congenital condition and/or previous or current illness and (or) medication use that could interfere with the study, in the opinion of the medical doctor.

Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet.

Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Actual
Primary Purpose: Basic Science
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Atlantia Food Clinical Trials

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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