Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorTaipei Medical University Shuang Ho Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mulberry fruit juice
- Mometasone furoate 0.1% cream
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov