A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.

This clinical study will be performed within TOP Institute Pharma (project T1-501). Besides Danone Research, also the Academic Medical Center (AMC) Amsterdam, Wilhelmina Children's Hospital (WKZ) Utrecht, VU University Amsterdam, and the Utrecht Institute for Pharmaceutical Sciences (UIPS) will participate in the TOP Institute Pharma project. Danone Research shall take care of the Sponsor responsibilities as defined by ICH-GCP'.0 sites144 target enrollmentTBD

ConditionsAtopic Dermatitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: This clinical study will be performed within TOP Institute Pharma (project T1-501). Besides Danone Research, also the Academic Medical Center (AMC) Amsterdam, Wilhelmina Children's Hospital (WKZ) Utrecht, VU University Amsterdam, and the Utrecht Institute for Pharmaceutical Sciences (UIPS) will participate in the TOP Institute Pharma project. Danone Research shall take care of the Sponsor responsibilities as defined by ICH-GCP'.
Enrollment: 144
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Hulshof L, Overbeek SA, Wyllie AL, Chu MLJN, Bogaert D, de Jager W, Knippels LMJ, Sanders EAM, van Aalderen WMC, Garssen J, Van ’t Land B, Sprikkelman AB. Exploring Immune Development in Infants With Moderate to Severe Atopic Dermatitis. Front Immunol., 2018;9:630.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Eligibility Criteria

Inclusion Criteria

•1\. Infants/children with atopic dermatitis;
•2\. Between 0\-8 months of age;

Exclusion Criteria

•1\. Intolerance for any other component of the study product(s);
•2\. History of anaphylactic reaction to cow's milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction;

Outcomes

Primary Outcomes

Not specified

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