Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT06636240

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

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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