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Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

NCT06943469 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-12

No results posted yet for this study

Summary

The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.

Conditions

  • Atopic Dermatitis (AD)

Interventions

OTHER

Test formula

Partially hydrolyzed formula with synbiotics

OTHER

Control formula

Intact protein formula without synbiotics

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2027-10-31
Completion
2028-11-30

Countries

  • Belgium
  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943469 on ClinicalTrials.gov