NCT06474728

Effects of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus on Pediatric Atopic Dermatitis

A Randomised Trial of an Emollient Containing Postbiotic Saccharomyces and Lactobacillus for Improving Clinical Symptoms of Atopic Dermatitis Aged 0-6 Years in Remission

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Month – 6 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to investigate whether the use of emollients containing postbiotic Saccharomyces and Lactobacillus can significantly reduce the risk of atopic dermatitis (AD) recurrence in pediatric patients aged 0-6 years during the remission phase, compared to the routine maintenance treatment with conventional emollients.

Detailed description

A single-center, randomized, parallel-controlled study was conducted to evaluate the efficacy of an emollient containing postbiotic Saccharomyces and Lactobacillus in 98 children aged 0 to 6 years with moderate AD. Participants were randomly assigned to the experimental group (49 cases) and the control group (49 cases). During the screening phase, hydrocortisone butyrate cream or desoximetasone cream was topically applied twice daily to the affected areas, along with the emollient twice daily for 2 to 4 weeks until the Investigator's Global Assessment (IGA) score was ≤1, indicating entry into the intervention phase. In the intervention phase, the experimental group discontinued the corticosteroid creams and continued with the emollient twice daily, while the control group discontinued both medication and emollient. The recurrence of AD, Eczema Area and Severity Index (EASI), Infant/Child Dermatology Quality of Life Index (IDQOL/CDQOL), and adverse events were assessed at weeks 4, 8, and 12 of the intervention phase. Additionally, non-invasive measurements of skin barrier function were conducted, including: Transepidermal water loss (TEWL) to assess water loss from the skin. Skin electrical capacitance to measure water retention in the stratum corneum. Skin pH to determine the skin's acidity level.

Conditions

• Atopic Dermatitis
• Eczema
• Emollient

Interventions

Type	Name	Description
OTHER	Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus	Treatment with an Emollient Containing Postbiotic Saccharomyces and Lactobacillus, with the dose of 100g per week,lasting for 12weeks.

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-01-06
• Completion: 2026-01-06
• First posted: 2024-06-26
• Last updated: 2026-04-08

Locations

1 site across 1 country: China