Dermatitis, Allergic ContactSOPRANONCT04182425
Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis
An observational study of Dermatitis, Allergic Contact and Infectious Diseases, run by Bledina at 1 site in France.
Trial summary
This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use. Read more about this study
- Who is it for?
- Ages Up to 5 weeksHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Allergic Contact, Infectious Diseases
- What is being tested?
- Infant formula
- How many people
- 334 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2019to 4 Jul 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 5 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants up to 1 month + 1 week, in good health, at risk of dysbiosis
Who may be able to join
- full-term infant (gestational age ≥ 37 and ≤ 42 weeks) in good health;
- Having at least one risk factor for dysbiosis, including:
- birth by caesarean section,
- Antibiotic exposure between birth and inclusion or in utero (mother who received antibiotics) during the last trimester of pregnancy, or per-partum (mother who received antibiotics during childbirth),
- a family history of allergy confirmed by a doctor in a family member, affecting at least one of the two parents or siblings (asthma, atopic dermatitis, eczema, allergic rhinitis, proven food allergy);
- Aged at most 5 weeks;
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- Having a weight in the reference values for gestational age and sex (between the 10th and the 90th percentiles according to the growth curves in force);
- Already consuming an infant formula (with or without associated breast milk), or whose mother wishes to introduce an infant formula at the end of this consultation to switch to mixed breastfeeding or to start weaning;
- Authorization of a parent (or both) or legal representative of the child to collect personal information about their child and family.
Who cannot join
- Premature infants or low birth weight (< 2500g);
- Infant allergic to cow's milk protein;
- Infants with severe congenital anomalies that may impact growth (cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, congenital heart defects ...);
- Infants with chronic disease or severe neonatal pathology, or a pathology predisposing to infections (HIV, hepatitis B or C, autoimmune diabetes, immune deficiency, respiratory distress, sepsis, intraventricular hemorrhage, severe neonatal hepatitis, necrotizing enterocolitis, hypertension persistent pulmonary ...), or renal or hepatic pathology;
- Inability of the parent or legal representative to understand the protocol of the study, or doubts of the physician on the ability or willingness to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-life Study to Assess the Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk of Dysbiosis During the First Year of Life
This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use.
Read the detailed description
The primary objective of the study is to evaluate the cumulative incidence of atopic dermatitis in healthy infants at risk for dysbiosis at 12 months of age and to identify factors associated with the presence of atopic dermatitis.
- Conditions
- Dermatitis, Allergic Contact, Infectious Diseases
- Being tested
- Infant formula
- Medical subject headings
- Dermatitis, Allergic Contact, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
Healthy full-term infants fed on an infant formula marketed on the French market
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of atopic dermatitis in the infants included in the study
Number of episodes of dermatitis reported during the 12 months of follow-up, and objectified by a SCORAD score > 0.
Measured: 12 months
Secondary outcomes (10)
Atopic dermatitis
Cumulative incidence of episodes of moderate atopic dermatitis (SCORAD score of 25 to 50) or severe episodes (SCORAD score> 50)
Measured: 3, 6 and 12 months
Gastrointestinal tolerance
- Frequency, consistency, color and quantity of stool (Amsterdam scale),
- Frequency and intensity of regurgitations (adapted score of Vandenplas),
- Frequency and intensity of gas / bloating, colic, unexplained crying
Measured: 3, 6 and 12 months
Height
Growth in term of height
Measured: 3, 6 and 12 months
Weight
Growth in term of weight
Measured: 3, 6 and 12 months
Cranial perimeter
Growth in terme of cranial perimeter
Measured: 3, 6 and 12 months
Observance
% of children who consumed the formula prescribed by the doctor at the previous visit
Measured: 3, 6 and 12 months
Consumption
Number of days of consumption during the previous period.
Measured: 3, 6 and 12 months
Satisfaction with Likert scale
5-level Likert scale filled in by the doctor and by parents
Measured: 3, 6 and 12 months
Cumulative incidence of allergic manifestations
Cumulative number since the inclusion of episodes of:
- atopic dermatitis,
- eczema,
- wheezing,
- allergic rhinitis
Measured: 3, 6 and 12 months
Cumulative incidence of infections
Cumulative number since the inclusion of episodes of:
- Infection of the upper respiratory tract,
- Infection of the lower respiratory tract,
- Gastrointestinal infections,
- pyelonephritis,
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start7 Dec 2019
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, Allergic ContactStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bledina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florence MD CAMPEOTTO, Study chair, Scientific CommitteeHugues MD PILOQUET, Study chair, Scientific CommitteeAlexis MD MOSCA, Study chair, Scientific CommitteeOlivier MD GOULET, Study chair, Scientific CommitteeMarie-José MD BUTEL, Study chair, Scientific CommitteeAnne-Judith MD WALIGORA, Study chair, Scientific Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182425
- Sponsor's protocol ID
- 2019-A01725-52
- Acronym
- SOPRANO
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2019
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Study to Assess the Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk of Dysbiosis During the First Year of Life
- ClinicalTrials.gov ID
- NCT04182425
- Acronym / sponsor ID
- SOPRANO / 2019-A01725-52
- Conditions
- Dermatitis, Allergic Contact, Infectious Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- BledinaIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 2 Dec 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.
This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use.
Detailed description
The primary objective of the study is to evaluate the cumulative incidence of atopic dermatitis in healthy infants at risk for dysbiosis at 12 months of age and to identify factors associated with the presence of atopic dermatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- Up to 5 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants up to 1 month + 1 week, in good health, at risk of dysbiosis
Key inclusion criteria (9 listed)
- full-term infant (gestational age ≥ 37 and ≤ 42 weeks) in good health;
- Having at least one risk factor for dysbiosis, including:
- Aged at most 5 weeks;
- Having a weight in the reference values for gestational age and sex (between the 10th and the 90th percentiles according to the growth curves in force);
- Already consuming an infant formula (with or without associated breast milk), or whose mother wishes to introduce an infant formula at the end of this consultation to switch to mixed breastfeeding or to start weaning;
Key exclusion criteria (5 listed)
- Premature infants or low birth weight (< 2500g);
- Infant allergic to cow's milk protein;
- Infants with severe congenital anomalies that may impact growth (cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, congenital heart defects ...);
- Infants with chronic disease or severe neonatal pathology, or a pathology predisposing to infections (HIV, hepatitis B or C, autoimmune diabetes, immune deficiency, respiratory distress, sepsis, intraventricular hemorrhage, severe neonatal hepatitis, necrotizing enterocolitis, hypertension persistent pulmonary ...), or renal or hepatic pathology;
- Inability of the parent or legal representative to understand the protocol of the study, or doubts of the physician on the ability or willingness to comply with the protocol.
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 formulaHealthy full-term infants fed on an infant formula marketed on the French market | Other | – |
Primary outcome
Cumulative incidence of atopic dermatitis in the infants included in the study
Time frame: 12 months
Number of episodes of dermatitis reported during the 12 months of follow-up, and objectified by a SCORAD score > 0.
10 secondary outcomes
Atopic dermatitis
Time frame: 3, 6 and 12 months
Gastrointestinal tolerance
Time frame: 3, 6 and 12 months
Height
Time frame: 3, 6 and 12 months
Weight
Time frame: 3, 6 and 12 months
Cranial perimeter
Time frame: 3, 6 and 12 months
Observance
Time frame: 3, 6 and 12 months
Consumption
Time frame: 3, 6 and 12 months
Satisfaction with Likert scale
Time frame: 3, 6 and 12 months
Cumulative incidence of allergic manifestations
Time frame: 3, 6 and 12 months
Cumulative incidence of infections
Time frame: 3, 6 and 12 months
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 13 Mar 2023.
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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.
Florence MD CAMPEOTTO study chair
Scientific Committee
Hugues MD PILOQUET study chair
Scientific Committee
Alexis MD MOSCA study chair
Scientific Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Allergic Contact and Infectious Diseases, run by Bledina at 1 site in France.
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 9 inclusion and 5 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 13 Mar 2023. 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 France. 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?
Cumulative incidence of atopic dermatitis in the infants included in the study (time frame: 12 months). 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 13 Mar 2023.