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出境医 / 临床实验 / Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants. (WAVE)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Term Infants Other: milk based infant formula Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: 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.
Estimated Study Start Date : July 10, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Weight gain [ Time Frame: 17 weeks ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 17 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jan van der Mooren +31 30 2095 000 jan.vandermooren@danone.com

Sponsors and Collaborators
Nutricia Research
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 12, 2019
Estimated Study Start Date  ICMJE July 10, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		Weight gain [ Time Frame: 17 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy Term Infants
Intervention  ICMJE Other: milk based infant formula
Cows milk ased infant formula
Study Arms  ICMJE
  • Experimental: Test product
    Cow's milk based infant formula containing prebiotics and postbiotics
    Intervention: Other: milk based infant formula
  • Active Comparator: Control product
    Cow's milk based infant formula without prebiotics and postbiotics
    Intervention: Other: milk based infant formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		268
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jan van der Mooren +31 30 2095 000 jan.vandermooren@danone.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015050
Other Study ID Numbers  ICMJE EBB18FI23464
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nutricia Research
Study Sponsor  ICMJE Nutricia Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nutricia Research
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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