Effects of mulberry juice on eczema in children and adolescents
Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
This study is testing if drinking mulberry juice can help improve eczema symptoms in children and teenagers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Taipei Medical University Shuang Ho Hospital Academic / other |
| Locations | 2 sites (New Taipei City, Taiwan and 1 other locations) |
| Trial ID | NCT06636240 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to less than 18 years with a confirmed diagnosis of atopic dermatitis.
Not a fit: Patients with allergies to berries or related fruits, or those with significant immune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to help alleviate symptoms of atopic dermatitis in children and adolescents.
How similar studies have performed: While animal studies have shown promising results regarding the effects of mulberry on atopic dermatitis, this human study is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Taipei City, Taiwan and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.