Effects of mulberry juice on eczema in children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project investigates the prebiotic effects of mulberry juice on atopic dermatitis in children and adolescents through a randomized controlled trial. Up to 120 participants will be recruited from Taipei Medical University Hospital and divided into experimental and control groups. The study will involve a 3-month intervention with five clinical assessments and three stool collections to evaluate changes in atopic dermatitis severity, gut microbiota, and metabolites. The aim is to establish mulberry fruit as a potential adjunctive treatment for alleviating atopic dermatitis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 6 years and above (including 6 years) to less than 18 years (excluding 18 years)
* The legal guardian has the ability to understand and is willing to sign the written informed consent document
* Diagnosed by a physician according to the international Hanifin \& Rajka criteria for atopic dermatitis, with a confirmed diagnosis of more than six months

Exclusion Criteria:

* Allergic to berries, mulberries, fruits from the same family (such as figs), or similar chemical or biological components
* Patients with immunodeficiency, including congenital or acquired immune disorders
* Patients with 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
* Individuals with other diseases or mental disorders that prevent them from complying with the intervention plan
* Patients with Short Bowel Syndrome
* Received oral or injectable antibiotics in the past month
* Received immunomodulators, biologics, or oral/injectable steroids exceeding 2 mg/kg/day in the past three months
* Underwent major surgery within 28 days before the study intervention (including the 28th day) or have not recovered from the side effects or complications of drug treatment/surgery from four weeks prior
* Currently participating in other drug intervention studies
* Currently experiencing systemic infection or unexplained fever (ear temperature greater than or equal to 38°C)
* Pregnancy
* Premature infants (born before 37 weeks, excluding 37 weeks)
* Individuals with congenital diseases, nutritional or metabolic disorders, or keratinization disorders
* Diagnosed with malignancies within the past five years.

Where it's running

• Taipei Medical University-Shuang Ho Hospital
  New Taipei City, Taiwan, Taiwan Recruiting
• Taipei Medical University Shuang Ho Hospital
  New Taipei City, Taiwan Not yet recruiting

Study contacts

• Principal investigator: Taipei Medical University Shuang Ho Hospital — Taipei Medical University
• Study coordinator: Meng-Che Lu, M.D.
• Email: 13490@s.tmu.edu.tw
• Phone: +886970747887

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.