Atopic DermatitisPhase 3PIPANCT02116452
Prebiotics in Prevention of Atopy
A Phase 3 study testing Supplemented Formula in people with Atopic Dermatitis, run by Federico II University at 1 site in Italy.
Trial summary
The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease. Read more about this study
- Who is it for?
- Ages 1 week to 24 weeks
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Supplemented Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Feb 2014
- 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 1 week to 24 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age >37 and < 42 weeks.
- Birth weight > 2500 gr.
- At risk of atopy (see appendix 1).
- Informed consent signed by the parents (see appendix 3).
Who cannot join
- Congenital immunodeficiency
- Severe congenital disorders or malformations
- Born to mother with diabet
- Long term intake (> 7 consecutive days) of pro- or prebiotics
- Children who have already assumed ≥ 50 mL for feeding bottle of Formulas different from the one object of this study for up to a month.
- Parents expected not to be compliant with the study procedures
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Padova - Department of Pediatrics
Padova, Italy, 35128
About this study
Official title: Effects of GOS/PDX Supplemented Formula in Preventing and Modifying the History of Allergy and Acute Infections in a Population of Infants at Risk of Atopy
The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease.
Read the detailed description
This study is a prospective, double blind, randomised, 24 month study trial comparing formula with 50/50 mixture of GOS/PDX (Enfamil Premium Infant Formula 1 for children <6 months and Formula 2 for children ≥ 6 months) versus standard formula (Enfamil Premium Formula 1 and 2).
Study population is composed by newborns at risk for allergy that will be identified at time of delivery. Infants will be eligible if at least one parent or one older sibling have a physician-diagnosed atopic disease (asthma, allergic rhinoconjunctivitis , atopic dermatitis, allergic urticaria, and food allergy as follow described. At time of enrolment (within the first 4 weeks of life) infants will be randomised 1:1 to receive once they will start formula feeding before the day of the 6th month birthday.
- Conditions
- Atopic Dermatitis
- Being tested
- Supplemented Formula
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemented FormulaDietary supplement
50:50 mixture of GOS/PDX formula will be administered
| Study group | Role | What they receive |
|---|---|---|
| Breast Milk | No intervention | Breast FED newborns |
| Standard Formula | Placebo comparator | Standard Formula FED newborns |
| Supplemented Formula | Active comparator | GOS/PDX Formula FED newborns Receives: Dietary Supplement: Supplemented Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence
Cumulative incidence of atopic dermatitis at 36 and 48 weeks
Measured: 36 - 48 weeks
Secondary outcomes (1)
Severity
Severity of atopic dermatitis as judged by the SCORAD score at 36 and 48 weeks and its distribution in three different groups: mild (<15 SCORAD points), moderate (15-40 SCORAD points), and severe (>40 SCORAD points) according to the objective components of the index
Measured: 36-48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Principal investigator, Alfredo Guarino, Federico II University
- Investigators
- Alfredo Guarino, MD, Principal investigator, University of NaplesStefania Zanconato, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116452
- Sponsor's protocol ID
- PIPA
- Acronym
- PIPA
- Status last verified
- Feb 2011
- First submitted
- 15 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ranucci G, Buccigrossi V, Borgia E, Piacentini D, Visentin F, Cantarutti L, Baiardi P, Felisi M, Spagnuolo MI, Zanconato S, Baraldi E, Giaquinto C, Guarino A. Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial. Nutrients. 2018 Mar 1;10(3):286. doi: 10.3390/nu10030286.
PubMed 29494489
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GOS/PDX Supplemented Formula in Preventing and Modifying the History of Allergy and Acute Infections in a Population of Infants at Risk of Atopy
- ClinicalTrials.gov ID
- NCT02116452
- Acronym / sponsor ID
- PIPA / PIPA
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease.
Detailed description
This study is a prospective, double blind, randomised, 24 month study trial comparing formula with 50/50 mixture of GOS/PDX (Enfamil Premium Infant Formula 1 for children <6 months and Formula 2 for children ≥ 6 months) versus standard formula (Enfamil Premium Formula 1 and 2).
Study population is composed by newborns at risk for allergy that will be identified at time of delivery. Infants will be eligible if at least one parent or one older sibling have a physician-diagnosed atopic disease (asthma, allergic rhinoconjunctivitis , atopic dermatitis, allergic urticaria, and food allergy as follow described. At time of enrolment (within the first 4 weeks of life) infants will be randomised 1:1 to receive once they will start formula feeding before the day of the 6th month birthday.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Milk | No intervention | –Breast FED newborns |
| Standard Formula | Placebo comparator | –Standard Formula FED newborns |
| Supplemented Formula | Active comparator | Dietary Supplement: Supplemented FormulaGOS/PDX Formula FED newborns |
Who may qualify
- Ages
- 1 week to 24 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age >37 and < 42 weeks.
- Birth weight > 2500 gr.
- At risk of atopy (see appendix 1).
- Informed consent signed by the parents (see appendix 3).
Key exclusion criteria (6 listed)
- Congenital immunodeficiency
- Severe congenital disorders or malformations
- Born to mother with diabet
- Long term intake (> 7 consecutive days) of pro- or prebiotics
- Children who have already assumed ≥ 50 mL for feeding bottle of Formulas different from the one object of this study for up to a month.
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 |
|---|---|---|
| Supplemented Formula50:50 mixture of GOS/PDX formula will be administered | Dietary supplement | Supplemented Formula |
Primary outcome
Cumulative incidence
Time frame: 36 - 48 weeks
Cumulative incidence of atopic dermatitis at 36 and 48 weeks
1 secondary outcome
Severity
Time frame: 36-48 weeks
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 16 Apr 2014.
- Derived from this study: PubMed 29494489Ranucci G, Buccigrossi V, Borgia E, Piacentini D, Visentin F, Cantarutti L, Baiardi P, Felisi M, Spagnuolo MI, Zanconato S, Baraldi E, Giaquinto C, Guarino A. Galacto-Oligosaccharide/Polidextrose Enriched Formula Protects against Respiratory Infections in Infants at High Risk of Atopy: A Randomized Clinical Trial. Nutrients. 2018 Mar 1;10(3):286. doi: 10.3390/nu10030286.
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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.
Alfredo Guarino, MD principal investigator
University of Naples
Stefania Zanconato, MD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supplemented Formula in people with Atopic Dermatitis, run by Federico II University at 1 site in Italy.
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 4 inclusion and 6 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 16 Apr 2014. 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 Italy. 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. Some participants in this study may receive a placebo. 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 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?
Cumulative incidence (time frame: 36 - 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116452, which also lists 1 linked publication.
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 16 Apr 2014.