Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants (VOYAGE)

September 6, 2018 updated by: Nutricia Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Bialystok, Poland, 15-435
        • Recruiting
        • Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
        • Contact:
          • M Arciszewska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy, singleton, term infants
  2. Aged ≤14 days at randomisation/enrolment
  3. Birth weight within normal range for gestational age and sex
  4. Head circumference at birth within normal range for age and sex
  5. Maternal age ≥18 years at birth;
  6. 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);
  7. Written informed consent from parent(s) and/or legal guardian(s), who themselves are aged ≥18 years.

Exclusion Criteria:

  1. Infants who require to be fed a special diet other than standard cow's milk based infant formula;
  2. Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance;
  3. 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;
  4. 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;
  5. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;
  6. 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;

  7. 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:

  8. 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;
  9. Lactating women known to suffer from hepatitis B or human immunodeficiency virus;
  10. 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;
  11. Lactating women who intend to feed their infants with a combination of human milk and infant formula.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
Cows milk based infant formula containing fermented infant formula and prebiotic oligosaccharides
Other: Infant formula
Infants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age.
ACTIVE_COMPARATOR: Control
Cows milk based infant formula containing prebiotic oligosaccharides (commercially available Aptamil ProNutra)
Other: Infant formula
Infants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age.
NO_INTERVENTION: Breastfed reference
Exclusively breastfed from birth to study completion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
17 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight gain (human milk 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 human milk
17 weeks
Recumbent Length gain
Time Frame: 17 weeks
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
17 weeks
Head circumference gain
Time Frame: 17 weeks
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
17 weeks
Parent-reported GI Tolerance Parameters (daily diary)
Time Frame: 17 weeks
Information on regurgitation and vomiting will be collected by a daily diary that is completed by the parents.
17 weeks
Parent-Reported Stool Characteristics (adapted Amsterdam Stool Scale)
Time Frame: 17 weeks
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.
17 weeks
Incidence of treatment-related adverse events
Time Frame: 17 weeks
Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA) as assessed and reported by the investigator.
17 weeks
Severity of treatment-related adverse events
Time Frame: 17 weeks
Severity of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA) as assessed and reported by the investigator.
17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBB17TA14644

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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