Clinical trial NCT04182425: Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis, Allergic Contact
Infectious Diseases
Lead sponsor: Bledina
Sponsor class: INDUSTRY
First posted: 2019-12-02
Enrollment: 334
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants up to 1 month + 1 week, in good health, at risk of dysbiosis

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cumulative incidence of atopic dermatitis in the infants included in the study
timeFrame: 12 months
Secondary outcomes:
measure: Atopic dermatitis
timeFrame: 3, 6 and 12 months
measure: Gastrointestinal tolerance
timeFrame: 3, 6 and 12 months
measure: Height
timeFrame: 3, 6 and 12 months
measure: Weight
timeFrame: 3, 6 and 12 months
measure: Cranial perimeter
timeFrame: 3, 6 and 12 months
measure: Observance
timeFrame: 3, 6 and 12 months
measure: Consumption
timeFrame: 3, 6 and 12 months
measure: Satisfaction with Likert scale
timeFrame: 3, 6 and 12 months
measure: Cumulative incidence of allergic manifestations
timeFrame: 3, 6 and 12 months
measure: Cumulative incidence of infections
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Taverny
country: France
facility: Medical Office
Study officials:
affiliation: Scientific Committee
name: Florence MD CAMPEOTTO
role: STUDY_CHAIR
affiliation: Scientific Committee
name: Hugues MD PILOQUET
role: STUDY_CHAIR
affiliation: Scientific Committee
name: Alexis MD MOSCA
role: STUDY_CHAIR
affiliation: Scientific Committee
name: Olivier MD GOULET
role: STUDY_CHAIR
affiliation: Scientific Committee
name: Marie-José MD BUTEL
role: STUDY_CHAIR
affiliation: Scientific Committee
name: Anne-Judith MD WALIGORA
role: STUDY_CHAIR
References: