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

NCT06636240 | Recruiting DMC

• 1 other identifier: 113TMU-SHH-29
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis (Eczema); Atopic Dermatitis, Probiotics

Outcome Measures

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.

  6 days until completion of juice intake

Secondary Outcomes (2)

• Change of the Scoring Atopic Dermatitis (SCORAD)

  From enrollment to the end of experiment at 12 weeks

• Change of the Children's Dermatology Life Quality Index (CDLQI)

  From enrollment to the end of experiment at 12 weeks

Study Arms (2)

control arm

ACTIVE COMPARATOR

standard atopic dermatitis treatment

Other: Mometasone furoate 0.1% cream

experimental arm

EXPERIMENTAL

add-on 200 ml/day mulberry juice with standard therapy

Dietary Supplement: Mulberry fruit juice

Interventions

Mulberry fruit juice DIETARY_SUPPLEMENT

Mulberry fruit juice 200ml/day plus standard therapy for atopic dermatitis including topical Mometasone furoate cream 0.1%

experimental arm

Mometasone furoate 0.1% cream OTHER

Standard therapy for atopic dermatitis including Mometasone furoate cream 0.1%

control arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (2)

Taipei Medical University-Shuang Ho Hospital

New Taipei City, Taiwan, 23561, Taiwan

RECRUITING

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Taipei Medical University Shuang Ho Hospital

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng-Che Lu, M.D.

CONTACT

+886970747887; 13490@s.tmu.edu.tw

Yu-Yuan Huang, Associate degree

CONTACT

08123@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Immunologist

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 10, 2024
• Study Start: March 17, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)