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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Term Infants
• Intervention / Treatment: Other: milk based infant formula

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland, 15-435
    • Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test product; Cow's milk based infant formula containing prebiotics and postbiotics	Other: milk based infant formula; Cows milk ased infant formula
Active Comparator: Control product; Cow's milk based infant formula without prebiotics and postbiotics	Other: milk based infant formula; Cows milk ased infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain	from baseline until the age of 17 weeks (test product versus control product). Weight gain will be calculated as weight (in grams) at visit minus weight at baseline divided by the number of days.	17 weeks

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 3, 2021

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EBB18FI23464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No