Actively Recruiting
Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched 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
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the potential prebiotic effects of mulberry fruit juice on children and adolescents with atopic dermatitis. It will investigate how consuming mulberry juice might influence the severity of the skin condition, gut microbiota, and metabolites. The study will enroll up to 120 participants aged 6 to under 18 years, focusing on those diagnosed with atopic dermatitis for more than six months. The project is supported by Taipei Medical University Hospital and commissioned by the Ministry of Health and Welfare. Participants will be randomly assigned to either a control group receiving standard atopic dermatitis treatment, including Mometasone furoate 0.1% cream, or an experimental group receiving the same standard therapy plus 200 ml of mulberry fruit juice daily. The intervention lasts three months, with five clinical assessments and three stool collections scheduled during this period. The study will compare changes in atopic dermatitis severity, gut microbiota composition, and metabolites between the two groups. During the study, participants will undergo regular evaluations including clinical assessments of skin condition and quality of life. Stool samples will be collected to analyze changes in gut bacteria and metabolic products. Researchers will measure changes in metabolism starting from six days after beginning juice intake and track atopic dermatitis severity and life quality over the full 12 weeks. The study includes monitoring for safety and adherence, with total participation lasting three months.
CONDITIONS
Brief 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 with atopic dermatitis by a physician using international criteria, confirmed for more than six months
You will not qualify if you...
- Allergy to berries, mulberries, figs, or similar chemical/biological components
- Immunodeficiency disorders, either congenital or acquired
- Immune-related diseases other than allergies, asthma, or allergic rhinitis
- Other diseases or mental disorders preventing compliance with the study
- Short Bowel Syndrome
- Use of oral or injectable antibiotics in the past month
- Use of immunomodulators, biologics, or high-dose steroids (over 2 mg/kg/day) in past three months
- Major surgery within 28 days before study or unresolved complications
- Participation in other drug intervention studies
- Current systemic infection or fever of 38�b0C or higher
- Pregnancy
- Premature birth before 37 weeks
- Congenital, nutritional, metabolic, or keratinization disorders
- Malignancy diagnosis within the past five years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants consume 200 ml/day mulberry fruit juice along with standard atopic dermatitis therapy or receive standard therapy alone over a 3-month period. The effects on atopic dermatitis severity, gut microbiota, and metabolites are evaluated.
Five clinical assessments and three stool collections during the intervention
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.
Y
Yu-Yuan Huang, Associate degree
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here