NCT06636240

Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis

Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched Mulberry Fruit in Children and Adolescents With Atopic Dermatitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This project proposes a randomized controlled human study to explore the prebiotic effects of consuming mulberry juice on atopic dermatitis in children and adolescents. The study aims to investigate the potential of mulberry fruit as a human prebiotic. This human study will recruit up to 120 participants from the Taipei Medical University Hospital (commissioned by the Ministry of Health and Welfare). Participants will be divided into experimental groups and a control group, with a 3-month intervention involving five clinical assessments and three stool collections. The goal is to compare the severity of atopic dermatitis, gut microbiota, and metabolite changes during the 6 days of mulberry juice consumption between the experimental and control groups. This project will help establish mulberry fruit as a potential human prebiotic and adjunctive treatment for alleviating atopic dermatitis in children.

Detailed description

The results of animal experiments have confirmed that mulberry fruit can improve atopic dermatitis. Its anti-inflammatory response is associated with the regulation of innate immune pathways and the restoration of skin barrier function. Additionally, mulberry extract may have prebiotic effects, altering the gut microbiota and metabolites to improve host health. Currently, mulberries are known to contain a significant amount of glucosides, with interleukin-17 isomer modulation being a major component. Therefore, mulberry fruit may have immune-regulatory effects, especially in Asian children and adolescents with elevated Th-17-related interleukin expression. However, it is paucity in research on the anti-inflammatory effects of mulberry fruit and its impact on gut microbiota in human atopic dermatitis. This project proposes a randomized controlled human study to explore the long-term effects of consuming mulberry juice on atopic dermatitis in children and adolescents, as well as the composition of gut microbiota and metabolites. The study aims to investigate the potential of mulberry fruit as a human prebiotic. A randomized controlled human study will recruit up to 120 participants from the Taipei Medical University Hospital (commissioned by the Ministry of Health and Welfare). Participants will be divided into experimental groups and a control group, with a 3-month intervention involving five clinical assessments and three stool collections. The goal is to compare the severity of atopic dermatitis, gut microbiota, and metabolite changes during the 3 months of mulberry juice consumption between the experimental and control groups. This project will help establish mulberry fruit as a potential human prebiotic and adjunctive treatment for alleviating atopic dermatitis in children. It will also lay the foundation for future research on effective component isolation and analysis, elucidating the impact of mulberry fruit on the composition of the human gut microbiota and metabolites.

Conditions

• Atopic Dermatitis (Eczema)
• Atopic Dermatitis, Probiotics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mulberry fruit juice	Mulberry fruit juice 200ml/day plus standard therapy for atopic dermatitis including topical Mometasone furoate cream 0.1%
OTHER	Mometasone furoate 0.1% cream	Standard therapy for atopic dermatitis including Mometasone furoate cream 0.1%

Timeline

• Start date: 2025-03-17
• Primary completion: 2026-02-01
• Completion: 2026-04-30
• First posted: 2024-10-10
• Last updated: 2025-05-25

Locations

2 sites across 1 country: Taiwan