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

NCT04182425 | Completed

• 1 other identifier: 2019-A01725-52
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Allergic Contact; Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Atopic dermatitis

  3, 6 and 12 months

• Gastrointestinal tolerance

  3, 6 and 12 months

• Height

  3, 6 and 12 months

• Weight

  3, 6 and 12 months

• Cranial perimeter

  3, 6 and 12 months

Interventions

Infant formula OTHER

Healthy full-term infants fed on an infant formula marketed on the French market

Eligibility Criteria

• Age: Up to 5 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bledina: lead

Study Sites (1)

Medical Office

Taverny, France

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact; Communicable Diseases

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: December 2, 2019
• Study Start: December 7, 2019
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

FR (1)