Actively Recruiting
Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
Led by Taipei Medical University Shuang Ho Hospital · Updated on 2025-05-25
120
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6 years and above to less than 18 years
- Legal guardian able to understand and willing to sign informed consent
- Diagnosed by a physician with atopic dermatitis for more than six months according to Hanifin & Rajka criteria
You will not qualify if you...
- Allergy to berries, mulberries, figs, or similar fruits or components
- Immunodeficiency disorders, including congenital or acquired
- Immune-related diseases other than allergies, asthma, or allergic rhinitis, including malignancies, rheumatic diseases, lupus erythematosus, chronic liver diseases, cirrhosis, kidney diseases, diabetes, or asplenia
- Other diseases or mental disorders preventing study compliance
- Short Bowel Syndrome
- Use of oral or injectable antibiotics in the past month
- Use of immunomodulators, biologics, or oral/injectable steroids over 2 mg/kg/day in the past three months
- Major surgery within 28 days before the study or ongoing complications from prior surgery or drug treatment
- Participation in other drug intervention studies
- Current systemic infection or unexplained fever with ear temperature ≥38°C
- Pregnancy
- Premature birth before 37 weeks
- Congenital diseases, nutritional or metabolic disorders, or keratinization disorders
- Malignancies diagnosed within the past five years
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, Taiwan, 23561
Actively Recruiting
2
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
Not Yet Recruiting
Research Team
M
Meng-Che Lu, M.D.
CONTACT
Y
Yu-Yuan Huang, Associate degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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