Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.

An Open-label Single-arm Study to Investigate Gastrointestinal Tolerance, Safety, and Acceptability of a New Infant Formula Containing Prebiotics, Probiotics and Postbiotics, in Healthy Term Infants.

NCT04745455•Nutricia Research

View on ClinicalTrials.gov

Summary

A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
•2. Singleton, healthy infants as judged by the principle investigator;
•3. Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
•4. Infants who are fully formula fed for at least 1 week prior to screening and whose parents have autonomously decided to fully formula feed, i.e. not to breastfeed or have ended breastfeeding, and who are intending to fully formula feed;
•5. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.

Exclusion Criteria

•1. Infants who require to be fed a special diet other than standard cow's milk-based infant formula;
•2. Infants known to have or suspected to have cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients;
•3. Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgment of the Investigator;
•4. Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;
•5. Infants with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator;
•6. Received any of the following products/medication prior to screening: systemic antibiotics, prokinetics, proton pump inhibitors, prebiotic supplements, probiotic supplements, complementary feeding/weaning within 4 weeks prior to screening;
•7. Incapability of infants' parents to comply with study protocol as per the judgment of the Investigator (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection);
•8. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.
•\-

Locations (3)

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K

Bialystok, Poland

Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne

Krakow, Poland

NZLA Michalkowice Jarosz i partnerzy Spolka

Siemianowice Śląskie, Poland

Key Dates

Start Date

January 22, 2021

Primary Completion Date

July 12, 2021

Completion Date

July 12, 2021

Last Updated

January 25, 2022

Enrollment

ACTUAL participants

Conditions

Gastrointestinal Tolerance

Interventions

Infant formula containing prebiotics, probiotics and postbiotics

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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