NCT06636240 Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis

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This trial targets 120 participants in total. It began in 2025-03-17 with a primary completion date of 2026-02-01.

Brief Summary

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.

Eligibility 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.

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