GrowthVOYAGENCT03476889
Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants
A study testing Infant formula in people with Growth, 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 a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 sitePoland
- Study dates
- 19 Jul 2018to 1 Mar 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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, singleton, term infants
- Aged ≤14 days at randomisation/enrolment
- Birth weight within normal range for gestational age and sex
- Head circumference at birth within normal range for age and sex
- Maternal age ≥18 years at birth;
- Intervention arms: exclusively formula fed at randomisation (infants of mothers who autonomously chose not to breastfeed for any reason before their infant is ≤14 days of age, and who intend to exclusively formula feed until their infant is at least 17 weeks of age); OR Breastfed reference arm: exclusively breastfed at enrolment (infants of mothers who intend to exclusively breastfeed until their infant is at least 17 weeks of age);
- Written informed consent from parent(s) and/or legal guardian(s), who themselves are aged ≥18 years.
Who cannot join
- Infants who require to be fed a special diet other than standard cow's milk based infant formula;
- Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance;
- Infants known or suspected to have current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters, as per the clinical judgement of the Investigator;
- Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters (including, but not limited to: GI malformations, congenital immunodeficiency), as per the clinical judgement of the Investigator;
- Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;
- Incapability of infants' parents/legally acceptable representatives to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parent(s)/legally acceptable representative(s) to comply with the protocol requirements;
Show all 12Show fewer
- Infants born from mothers with significant medical conditions during pregnancy that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication) as per Investigator's judgement.
- Criteria for lactating mothers of subjects in the breastfed reference arm:
- Lactating women who are currently participating or intend to participate in any other clinical study involving investigational products. Participation in purely observational studies is permitted;
- Lactating women known to suffer from hepatitis B or human immunodeficiency virus;
- Lactating women known to have any other significant medical condition(s) which might interfere with the study or its outcome parameters (breast abscess or mastitis which could interfere with lactation, or other clinically relevant infections, or consumption of medication/substances which could impact the infants' growth), as per the clinical judgement of the Investigator;
- Lactating women who intend to feed their infants with a combination of human milk and infant formula.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
Bialystok, 15-435
M Arciszewska
About this study
Official title: A Randomised, Controlled, Double-blind, Parallel Group, Multi-country Study to Investigate the Safety and Tolerance of a Partly Fermented Infant Formula Containing Prebiotic Oligosaccharides in Healthy Term Infants
A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants.
- Conditions
- Growth
- Being tested
- Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Infants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cows milk based infant formula containing fermented infant formula and prebiotic oligosaccharides Receives: Other: Infant formula |
| Control | Active comparator | Cows milk based infant formula containing prebiotic oligosaccharides (commercially available Aptamil ProNutra) Receives: Other: Infant formula |
| Breastfed reference | No intervention | Exclusively breastfed from birth to study completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain (infant formula comparison)
Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product
Measured: 17 weeks
Secondary outcomes (7)
Weight gain (human milk comparison)
Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving human milk
Measured: 17 weeks
Recumbent Length gain
Equivalence of length gain per day (mm/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product or human milk
Measured: 17 weeks
Head circumference gain
Equivalence of head circumference gain per day (mm/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product or human milk
Measured: 17 weeks
Parent-reported GI Tolerance Parameters (daily diary)
Information on regurgitation and vomiting will be collected by a daily diary that is completed by the parents.
Measured: 17 weeks
Parent-Reported Stool Characteristics (adapted Amsterdam Stool Scale)
Information on stool consistency (4-point scale) and stool frequency (number of stools per day) will be collected by a daily diary that is completed by the parents. Occurrence of diarrhea like-symptoms and constipation-like symptoms will be derived from the stool frequency and consistency data.
Measured: 17 weeks
Incidence of treatment-related adverse events
Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA) as assessed and reported by the investigator.
Measured: 17 weeks
Severity of treatment-related adverse events
Severity of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA) as assessed and reported by the investigator.
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 posted26 Mar 2018
- Study start19 Jul 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476889
- Sponsor's protocol ID
- EBB17TA14644
- Acronym
- VOYAGE
- Status last verified
- Mar 2018
- First submitted
- 12 Mar 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 10 Sep 2018. 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 a Partly Fermented Infant Formula Containing Prebiotic Oligosaccharides in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT03476889
- Acronym / sponsor ID
- VOYAGE / EBB17TA14644
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 26 Mar 2018 (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 a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Infant formulaCows milk based infant formula containing fermented infant formula and prebiotic oligosaccharides |
| Control | Active comparator | Other: Infant formulaCows milk based infant formula containing prebiotic oligosaccharides (commercially available Aptamil ProNutra) |
| Breastfed reference | No intervention | –Exclusively breastfed from birth to study completion |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy, singleton, term infants
- Aged ≤14 days at randomisation/enrolment
- Birth weight within normal range for gestational age and sex
- Head circumference at birth within normal range for age and sex
- Maternal age ≥18 years at birth;
Key exclusion criteria (12 listed)
- Infants who require to be fed a special diet other than standard cow's milk based infant formula;
- Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance;
- Infants known or suspected to have current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters, as per the clinical judgement of the Investigator;
- Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters (including, but not limited to: GI malformations, congenital immunodeficiency), as per the clinical judgement of the Investigator;
- Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;
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 |
|---|---|---|
| Infant formulaInfants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age. | Other | Control, Intervention |
Primary outcome
Weight gain (infant formula comparison)
Time frame: 17 weeks
Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product
7 secondary outcomes
Weight gain (human milk comparison)
Time frame: 17 weeks
Recumbent Length gain
Time frame: 17 weeks
Head circumference gain
Time frame: 17 weeks
Parent-reported GI Tolerance Parameters (daily diary)
Time frame: 17 weeks
Parent-Reported Stool Characteristics (adapted Amsterdam Stool Scale)
Time frame: 17 weeks
Incidence of treatment-related adverse events
Time frame: 17 weeks
Severity of treatment-related adverse events
Time frame: 17 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Growth
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula in people with Growth, 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan van der Mooren, MD, PhD (+31 30 295000, jan.vandermooren@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (infant formula comparison) (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 10 Sep 2018.