Healthy Term InfantsWAVENCT04015050
Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.
A study testing milk based infant formula in people with Healthy Term Infants, run by Nutricia Research at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 17 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- milk based infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jul 2019to 3 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 17 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
Bialystok, 15-435
About this study
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.
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
- Being tested
- milk based infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk based infant formulaOther
Cows milk ased infant formula
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Cow's milk based infant formula containing prebiotics and postbiotics Receives: Other: milk based infant formula |
| Control product | Active comparator | Cow's milk based infant formula without prebiotics and postbiotics Receives: Other: milk based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start10 Jul 2019
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Term InfantsStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015050
- Sponsor's protocol ID
- EBB18FI23464
- Acronym
- WAVE
- Status last verified
- Dec 2021
- First submitted
- 4 Jul 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04015050
- Acronym / sponsor ID
- WAVE / EBB18FI23464
- Conditions
- Healthy Term Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Other: milk based infant formulaCow's milk based infant formula containing prebiotics and postbiotics |
| Control product | Active comparator | Other: milk based infant formulaCow's milk based infant formula without prebiotics and postbiotics |
Who may qualify
- Ages
- 0 days to 17 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milk based infant formulaCows milk ased infant formula | Other | Control product, Test product |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk based infant formula in people with Healthy Term Infants, run by Nutricia Research at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.