Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.

NCT ID: NCT04015050

Last Updated: 2021-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2021-12-03

Brief Summary

A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of infant formula with prebiotics and postbiotics in healthy term infants.

Conditions

Healthy Term Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Test product

Cow's milk based infant formula containing prebiotics and postbiotics

Group Type: EXPERIMENTAL

milk based infant formula

Intervention Type: OTHER

Cows milk ased infant formula

Control product

Cow's milk based infant formula without prebiotics and postbiotics

Group Type: ACTIVE_COMPARATOR

milk based infant formula

Intervention Type: OTHER

Cows milk ased infant formula

Interventions

milk based infant formula

Cows milk ased infant formula

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1. Healthy, singleton, term infants (gestational age ≥37 weeks + 0 days and ≤41weeks + 6 days);

2. Infants with age at screening ≤14 days;

3. Birth weight within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards;

4. Head circumference at screening within ±2 SD per age and sex according to WHO Child Growth Standards;

5. a Randomised groups: Infants who are exclusively formula fed and/or whose mothers have autonomously decided to exclusively formula feed, i.e. not to breastfeed or have ended breastfeeding before screening, and who are intending to exclusively formula feed at least till their infant is 17 weeks of age; OR b Breastfed reference group: Infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed at least till their infant is 17 weeks of age;

6. Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years at screening.

Exclusion Criteria

• 1. Randomised groups: Infants who require a special diet other than non-hydrolysed, cow's milk based infant formula (e.g. due to known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance);

2. Infants with current or previous illnesses/conditions and/or 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 judgement of the Investigator;

3. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;

4. Incapability of infants' parents to comply with study protocol as per the judgement of the Investigator;

5. Infants born from mothers known to have (any) hepatitis or human immunodeficiency virus;

6. Infants born from mothers with significant medical conditions during pregnancy that might interfere with the study or its outcome parameters or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, Type 1, 2 diabetes) as per clinical judgement of the Investigator;

7. Infants born from mothers, who did participate in any clinical study involving investigational products during pregnancy, and for infants in Breastfed reference group: mothers who are currently participating or intend to participate in any clinical study involving investigational products during lactation.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 17 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.

Bialystok, , Poland

Countries

Poland

Other Identifiers

EBB18FI23464

Identifier Type: -

Identifier Source: org_study_id