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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Allergic Contact; Infectious Diseases
• Intervention / Treatment: Other: Infant formula

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 Type: Observational
• Enrollment (Actual): 334

Contacts and Locations

Study Locations

• France
  • Taverny, France
    • Medical Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants up to 1 month + 1 week, in good health, at risk of dysbiosis

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bledina
• Investigators: Study Chair: Florence MD CAMPEOTTO, Scientific Committee; Study Chair: Hugues MD PILOQUET, Scientific Committee; Study Chair: Alexis MD MOSCA, Scientific Committee; Study Chair: Olivier MD GOULET, Scientific Committee; Study Chair: Marie-José MD BUTEL, Scientific Committee; Study Chair: Anne-Judith MD WALIGORA, Scientific Committee

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2019
• Primary Completion (Actual): July 4, 2022
• Study Completion (Actual): July 4, 2022

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Disease Attributes; Hypersensitivity; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Infections; Communicable Diseases; Dermatitis; Dermatitis, Allergic Contact; Dysbiosis
• Other Study ID Numbers: 2019-A01725-52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No