Trials Sponsors Conditions Drugs Pricing

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
+5 more secondary outcomes

Interventions

Infant formulaOther

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 5 Weeks

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Sampling MethodProbability 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;

Sponsors & Collaborators

Bledina
Industrylead

Study Sites (1)

Medical Office

Taverny, France

MeSH Terms

Conditions

Dermatitis, Allergic ContactCommunicable Diseases

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, DelayedHypersensitivityImmune System DiseasesInfectionsDisease AttributesPathologic Processes

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

Enrollment

334 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations