Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis


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.

Full Title of Study: “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

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2021

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.


  • Other: Infant formula
    • Healthy full-term infants fed on an infant formula marketed on the French market

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Atopic dermatitis
    • Time Frame: 3, 6 and 12 months
    • Cumulative incidence of episodes of moderate atopic dermatitis (SCORAD score of 25 to 50) or severe episodes (SCORAD score> 50)
  • Gastrointestinal tolerance
    • Time Frame: 3, 6 and 12 months
    • 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
  • Height
    • Time Frame: 3, 6 and 12 months
    • Growth in term of height
  • Weight
    • Time Frame: 3, 6 and 12 months
    • Growth in term of weight
  • Cranial perimeter
    • Time Frame: 3, 6 and 12 months
    • Growth in terme of cranial perimeter
  • Observance
    • Time Frame: 3, 6 and 12 months
    • % of children who consumed the formula prescribed by the doctor at the previous visit
  • Consumption
    • Time Frame: 3, 6 and 12 months
    • Number of days of consumption during the previous period.
  • Satisfaction with Likert scale
    • Time Frame: 3, 6 and 12 months
    • 5-level Likert scale filled in by the doctor and by parents
  • Cumulative incidence of allergic manifestations
    • Time Frame: 3, 6 and 12 months
    • Cumulative number since the inclusion of episodes of: atopic dermatitis, eczema, wheezing, allergic rhinitis
  • Cumulative incidence of infections
    • Time Frame: 3, 6 and 12 months
    • Cumulative number since the inclusion of episodes of: Infection of the upper respiratory tract, Infection of the lower respiratory tract, Gastrointestinal infections, pyelonephritis,

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 5 Weeks

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bledina
  • Provider of Information About this Clinical Study
    • Sponsor

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