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

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Change of Metabolism [Time frame: 6 days until completion of juice intake]

Secondary outcome measures (2)

• Change of the Scoring Atopic Dermatitis (SCORAD) [Time frame: From enrollment to the end of experiment at 12 weeks]
• Change of the Children's Dermatology Life Quality Index (CDLQI) [Time frame: From enrollment to the end of experiment at 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

Taiwan · 2 centers

• Taipei Medical University-Shuang Ho Hospital — New Taipei City
• Taipei Medical University Shuang Ho Hospital — New Taipei City

Identifiers

NCT: NCT06636240 · 113TMU-SHH-29

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗