ImmunityPhase 3MAESTRONCT03062995
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
A Phase 3 study testing Infant Formula with added synbiotics and Standard Infant formula in people with Immunity, run by Nutricia Research.
Trial summary
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Read more about this study
- Who is it for?
- Ages Up to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Immunity
- What is being tested?
- Infant Formula with added synbiotics and Standard Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Dec 2023
- Phase
- Phase 3
- 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 Up to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks) at high risk of developing allergy based on family history of allergy (*1).
- Infants aged ≤ 16 weeks (max. 16 weeks + 0 days), preferably as soon as possible after birth.
- Infants who start formula feeding within 16 weeks of age (infants of mothers who have chosen not to breastfeed or mothers who completely/partially cease breastfeeding before the subject's age of 16 weeks)(*2) OR Infants who are exclusively breastfed and whose mothers have the intention to exclusively breastfeed at least until their infant is 16 weeks of age (*2,3).
- Written informed consent from one or both parents (according to local laws) and/or legal guardian.
- 1 Family history of allergy is defined as at least one first-degree relative (parent or full sibling) with: self-reported historically doctor confirmed allergic disease (allergic rhinitis, asthma, food allergy, allergic eczema). In case of a self-reported historically non-doctor confirmed allergic disease doctor confirmation must be done as part of the screening procedure according to local practice (e.g. skin prick test, IgE measurement).
- 2 Subjects whose mother intents to switch to formula feeding before the subject's age of 16 weeks but in the end still exclusively breastfeed, will be included in the breastfed reference group. The other way around, subjects whose mother intents to exclusively breastfeed for at least 16 weeks, but in the end decides to switch to formula earlier, will be included in the randomised groups. All these subject s should meet all other in-/exclusion criteria.
- 3 Exclusive breast feeding. WHO definition: only breast milk and no other liquids or solids except for drops or syrups consisting of vitamins, mineral supplements or medicines [2]. In addition to the WHO definition, in this study water is allowed as well as formula feeding during the first 72 hours of life.
Who cannot join
- Consumption of any amount of infant formula based on intact protein before randomisation, except for consumption during the first 72 hours of life.
- Consumption of any amount of infant formula with added probiotics and/or probiotic supplement before randomisation.
- Existing allergic manifestations (e.g. allergic skin disorders, food allergy) before randomisation according to investigator's clinical assessment.
- Severe congenital abnormalities which could influence the subjects' growth (e.g. cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, major congenital heart disease, or any other condition according to investigator's clinical judgement).
- Severe neonatal illnesses (e.g. respiratory distress syndrome, severe sepsis intraventricular hemorrhage, severe neonatal jaundice, necrotizing enterocolitis, persistent pulmonary hypertension of the newborn, or any other condition which required the use of intravenous and/or intramuscular antibiotics).
- Known underlying disease predisposing to infection (e.g. HIV, viral hepatitis B, and C, auto-immune diabetes, immune deficiency).
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- Severe renal failure and hepatic failure according to investigator's clinical judgement.
- Incapability of the parents to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- Participation in other studies involving investigational or marketed products concomitantly or within two weeks prior to screening visit.
About this study
Official title: A Randomised, Double-blind, Controlled, Parallel-group, Multi-country Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Infant formulas based on hydrolysed proteins have been developed to be used by infants at increased risk of developing allergy in case a mother is unable or chooses not to breastfeed her infant. The effect of hydrolysed formula in allergy prevention has been examined in many studies, from which it can be concluded that currently there is not sufficient evidence to support hydrolysed protein over intact protein for allergy risk reduction. Moreover, several clinical trials support the suggestion of supplementation of pre and/or probiotics for the reduction of eczema development, recognized by international authorities. The present study (MAESTRO) investigates the preventive effect of a hypoallergenic concept combining several nutritional approaches related to preventive strategies: partially hydrolysed protein formula supplemented with prebiotics and probiotics. The aim of the present study is to investigate the efficacy, growth and safety of this concept compared to standard (intact protein) infant formula on the development of allergic manifestations up to the age of 12 months in infants at increased risk of developing allergy.
- Conditions
- Immunity
- Being tested
- Infant Formula with added synbiotics, Standard Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula with added synbioticsOther
Intervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics.
Standard Infant formulaOther
Control group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics).
| Study group | Role | What they receive |
|---|---|---|
| Active product: partially hydrolysed formula + synbiotics | Experimental | partially hydrolysed formula + synbiotics Receives: Other: Infant Formula with added synbiotics |
| Control product: standard formula (intact protein) | Active comparator | standard formula (intact protein) Receives: Other: Standard Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic manifestations (IgE-mediated)
Doctor diagnosed IgE-mediated allergic manifestations
Measured: 54 weeks
Secondary outcomes (1)
Allergic manifestations (IgE-mediated and non IgE-mediated)
Doctor diagnosed IgE-mediated allergic manifestations and non IgE-mediated allergic manifestations
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startJun 2019 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study design not adequate anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT03062995
- Sponsor's protocol ID
- EBB15BL89859
- Acronym
- MAESTRO
- Status last verified
- Dec 2021
- First submitted
- 1 Feb 2017
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Controlled, Parallel-group, Multi-country Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
- ClinicalTrials.gov ID
- NCT03062995
- Acronym / sponsor ID
- MAESTRO / EBB15BL89859
- Conditions
- Immunity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design not adequate anymore
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Feb 2017 (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.
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority. It is generally acknowledged that breastfeeding is one of the main pillars in allergy prevention. Infant formulas based on hydrolysed proteins have been developed to be used by infants at increased risk of developing allergy in case a mother is unable or chooses not to breastfeed her infant. The effect of hydrolysed formula in allergy prevention has been examined in many studies, from which it can be concluded that currently there is not sufficient evidence to support hydrolysed protein over intact protein for allergy risk reduction. Moreover, several clinical trials support the suggestion of supplementation of pre and/or probiotics for the reduction of eczema development, recognized by international authorities. The present study (MAESTRO) investigates the preventive effect of a hypoallergenic concept combining several nutritional approaches related to preventive strategies: partially hydrolysed protein formula supplemented with prebiotics and probiotics. The aim of the present study is to investigate the efficacy, growth and safety of this concept compared to standard (intact protein) infant formula on the development of allergic manifestations up to the age of 12 months in infants at increased risk of developing allergy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active product: partially hydrolysed formula + synbiotics | Experimental | Other: Infant Formula with added synbioticspartially hydrolysed formula + synbiotics |
| Control product: standard formula (intact protein) | Active comparator | Other: Standard Infant formulastandard formula (intact protein) |
Who may qualify
- Ages
- Up to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks) at high risk of developing allergy based on family history of allergy (*1).
- Infants aged ≤ 16 weeks (max. 16 weeks + 0 days), preferably as soon as possible after birth.
- Infants who start formula feeding within 16 weeks of age (infants of mothers who have chosen not to breastfeed or mothers who completely/partially cease breastfeeding before the subject's age of 16 weeks)(*2) OR Infants who are exclusively breastfed and whose mothers have the intention to exclusively breastfeed at least until their infant is 16 weeks of age (*2,3).
- Written informed consent from one or both parents (according to local laws) and/or legal guardian.
Key exclusion criteria (9 listed)
- Consumption of any amount of infant formula based on intact protein before randomisation, except for consumption during the first 72 hours of life.
- Consumption of any amount of infant formula with added probiotics and/or probiotic supplement before randomisation.
- Existing allergic manifestations (e.g. allergic skin disorders, food allergy) before randomisation according to investigator's clinical assessment.
- Severe congenital abnormalities which could influence the subjects' growth (e.g. cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, major congenital heart disease, or any other condition according to investigator's clinical judgement).
- Severe neonatal illnesses (e.g. respiratory distress syndrome, severe sepsis intraventricular hemorrhage, severe neonatal jaundice, necrotizing enterocolitis, persistent pulmonary hypertension of the newborn, or any other condition which required the use of intravenous and/or intramuscular antibiotics).
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 Formula with added synbioticsIntervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics. | Other | Active product: partially hydrolysed formula + synbiotics |
| Standard Infant formulaControl group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics). | Other | Control product: standard formula (intact protein) |
Primary outcome
Allergic manifestations (IgE-mediated)
Time frame: 54 weeks
Doctor diagnosed IgE-mediated allergic manifestations
1 secondary outcome
Allergic manifestations (IgE-mediated and non IgE-mediated)
Time frame: 54 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infant Formula with added synbiotics and Standard Infant formula in people with Immunity, run by Nutricia Research.
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 9 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: withdrawn, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Allergic manifestations (IgE-mediated) (time frame: 54 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 23 Dec 2021.