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

Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched Mulberry Fruit in Children and Adolescents With Atopic Dermatitis

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis (Eczema); Atopic Dermatitis, Probiotics
• Intervention / Treatment: Other: Mometasone furoate 0.1% cream; Dietary supplement: Mulberry fruit juice

Detailed Description

The results of animal experiments have confirmed that mulberry fruit can improve atopic dermatitis. Its anti-inflammatory response is associated with the regulation of innate immune pathways and the restoration of skin barrier function. Additionally, mulberry extract may have prebiotic effects, altering the gut microbiota and metabolites to improve host health. Currently, mulberries are known to contain a significant amount of glucosides, with interleukin-17 isomer modulation being a major component. Therefore, mulberry fruit may have immune-regulatory effects, especially in Asian children and adolescents with elevated Th-17-related interleukin expression. However, it is paucity in research on the anti-inflammatory effects of mulberry fruit and its impact on gut microbiota in human atopic dermatitis.

This project proposes a randomized controlled human study to explore the long-term effects of consuming mulberry juice on atopic dermatitis in children and adolescents, as well as the composition of gut microbiota and metabolites. The study aims to investigate the potential of mulberry fruit as a human prebiotic. A randomized controlled 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 3 months 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. It will also lay the foundation for future research on effective component isolation and analysis, elucidating the impact of mulberry fruit on the composition of the human gut microbiota and metabolites.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng-Che Lu, M.D.; Phone Number: +886970747887; Email: 13490@s.tmu.edu.tw
• Study Contact Backup: Name: Yu-Yuan Huang, Associate degree; Email: 08123@s.tmu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 23561
    • Recruiting
    • Taipei Medical University-Shuang Ho Hospital
    • Contact: Meng-Che Lu; Phone Number: +886970747887; Email: 13490@s.tmu.edu.tw
  • New Taipei City, Taiwan
    • Not yet recruiting
    • Taipei Medical University Shuang Ho Hospital
    • Contact: Meng-Che Lu, M.D.; Phone Number: +886970747887; Email: 13490@s.tmu.edu.tw
    • Principal Investigator: Meng-Che Lu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control arm; standard atopic dermatitis treatment	Other: Mometasone furoate 0.1% cream; Standard therapy for atopic dermatitis including Mometasone furoate cream 0.1%
Experimental: experimental arm; add-on 200 ml/day mulberry juice with standard therapy	Dietary supplement: Mulberry fruit juice; Mulberry fruit juice 200ml/day plus standard therapy for atopic dermatitis including topical Mometasone furoate cream 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 days until completion of juice intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From enrollment to the end of experiment at 12 weeks
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.	From enrollment to the end of experiment at 12 weeks

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Taipei Medical University Shuang Ho Hospital, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: 113TMU-SHH-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No