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

Infectious Diseases Clinical Trial

— SOPRANO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182425
• Other study ID #: 2019-A01725-52
• Status: Completed
• Start date: December 7, 2019
• Est. completion date: July 4, 2022

Study information

• Verified date: March 2023
• Source: Bledina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: July 4, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Dermatitis
• Dermatitis, Allergic Contact
• Dysbiosis
• Infections
• Infectious Diseases

Intervention

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

Locations

Country	Name	City	State
France	Medical Office	Taverny

Sponsors (1)

Lead Sponsor	Collaborator
Bledina

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Height	Growth in term of height	3, 6 and 12 months
Secondary	Weight	Growth in term of weight	3, 6 and 12 months
Secondary	Cranial perimeter	Growth in terme of cranial perimeter	3, 6 and 12 months
Secondary	Observance	% of children who consumed the formula prescribed by the doctor at the previous visit	3, 6 and 12 months
Secondary	Consumption	Number of days of consumption during the previous period.	3, 6 and 12 months
Secondary	Satisfaction with Likert scale	5-level Likert scale filled in by the doctor and by parents	3, 6 and 12 months
Secondary	Cumulative incidence of allergic manifestations	Cumulative number since the inclusion of episodes of: atopic dermatitis,; eczema,; wheezing,; allergic rhinitis	3, 6 and 12 months
Secondary	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