Trials / Recruiting
RecruitingNCT06943469
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Société des Produits Nestlé (SPN) · Industry
- Sex
- All
- Age
- 1 Day – 14 Days
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Test formula | Partially hydrolyzed formula with synbiotics |
| OTHER | Control formula | Intact protein formula without synbiotics |
Timeline
- Start date
- 2025-04-10
- Primary completion
- 2027-10-01
- Completion
- 2028-11-01
- First posted
- 2025-04-24
- Last updated
- 2025-12-12
Locations
23 sites across 4 countries: Belgium, France, Germany, Spain
Source: ClinicalTrials.gov record NCT06943469. Inclusion in this directory is not an endorsement.