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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Mulberry fruit juice
Dietary supplementMulberry fruit juice 200ml/day plus standard therapy for atopic dermatitis including topical Mometasone furoate cream 0.1%
Mometasone furoate 0.1% cream
Other interventionStandard therapy for atopic dermatitis including Mometasone furoate cream 0.1%
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: control armActive comparator 1 intervention
Group B: experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change of Metabolism
Stool abundance statistical analysis at genus and species level, including richness, Chao1 index, Shannon and Simpson index, of gut microbiota from stool specimen collected from participants on 1st day and 8th day.
Time frame
6 days until completion of juice intakeSecondary outcomes
1
Change of the Scoring Atopic Dermatitis (SCORAD)
Evaluate the Scoring Atopic Dermatitis (SCORAD) scores on 1st day, 3rd, 6th, 9th and 12th week. The Score range is between 0 and 103 points and defines three classes of AD severity (i.e. mild if SCORAD \<25, moderate if 25 ≤ SCORAD ≤ 50 and severe if SCORAD \> 50)
Time frame
From enrollment to the end of experiment at 12 weeks2
Change of the Children's Dermatology Life Quality Index (CDLQI)
Evaluate the Children's Dermatology Life Quality Index (CDLQI) scores on 1st day, 3rd, 6th, 9th and 12th week. The minimum score is 0 and the maximum score is 30. Higher scores mean worse outcome.
Time frame
From enrollment to the end of experiment at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov