Atopic Dermatitis (Eczema)NCT06636240
Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
A study testing Mulberry fruit juice and Mometasone furoate 0.1% cream in people with Atopic Dermatitis (Eczema) and Atopic Dermatitis, Probiotics, run by Taipei Medical University Shuang Ho Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Atopic Dermatitis (Eczema), Atopic Dermatitis, Probiotics
- What is being tested?
- Mulberry fruit juice and Mometasone furoate 0.1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 17 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yu-Yuan Huang, Associate degree contact
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Meng-Che Lu, +886970747887, 13490@s.tmu.edu.tw
- Not yet recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City
Meng-Che Lu, M.D., +886970747887, 13490@s.tmu.edu.tw
Meng-Che Lu, M.D.
About this study
Official title: 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.
Read the 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.
- Being tested
- Mulberry fruit juice, Mometasone furoate 0.1% cream
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry fruit juiceDietary supplement
Mulberry fruit juice 200ml/day plus standard therapy for atopic dermatitis including topical Mometasone furoate cream 0.1%
Mometasone furoate 0.1% creamOther
Standard therapy for atopic dermatitis including Mometasone furoate cream 0.1%
| Study group | Role | What they receive |
|---|---|---|
| control arm | Active comparator | standard atopic dermatitis treatment Receives: Other: Mometasone furoate 0.1% cream |
| experimental arm | Experimental | add-on 200 ml/day mulberry juice with standard therapy Receives: Dietary Supplement: Mulberry fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days until completion of juice intake
Secondary outcomes (2)
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)
Measured: 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.
Measured: From enrollment to the end of experiment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start17 Mar 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Eczema)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Che Lu, Taipei Medical University Shuang Ho Hospital
- Investigators
- Taipei Medical University Shuang Ho Hospital, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636240
- Sponsor's protocol ID
- 113TMU-SHH-29
- Status last verified
- May 2025
- First submitted
- 10 Sep 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06636240
- Acronym / sponsor ID
- 113TMU-SHH-29
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | Active comparator | Other: Mometasone furoate 0.1% creamstandard atopic dermatitis treatment |
| experimental arm | Experimental | Dietary Supplement: Mulberry fruit juiceadd-on 200 ml/day mulberry juice with standard therapy |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulberry fruit juiceMulberry fruit juice 200ml/day plus standard therapy for atopic dermatitis including topical Mometasone furoate cream 0.1% | Dietary supplement | experimental arm |
| Mometasone furoate 0.1% creamStandard therapy for atopic dermatitis including Mometasone furoate cream 0.1% | Other | control arm |
Primary outcome
Change of Metabolism
Time frame: 6 days until completion of juice intake
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu-Yuan Huang, Associate degree contact
Taipei Medical University Shuang Ho Hospital principal investigator
Taipei Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry fruit juice and Mometasone furoate 0.1% cream in people with Atopic Dermatitis (Eczema) and Atopic Dermatitis, Probiotics, run by Taipei Medical University Shuang Ho Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng-Che Lu, M.D. (+886970747887, 13490@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Metabolism (time frame: 6 days until completion of juice intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.