Atopic DermatitisNCT05437887
Effects of Fucoidan on the Gut Microbiota in the Patients of Atopic Dermatitis
A study testing Fucoidan in people with Atopic Dermatitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Forty patients with physician-identified atopic dermatitis will be enrolled in the study. All patients must be aged between 6 and 60 years old. All patients consumed fucoidan for 3 months. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Fucoidan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2022to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Volunteer for study enrollment and sign inform consent
- The age of the patients must be between 6 and 60 years old. Both men and women can participate.
- Symptoms meet the diagnostic criteria of Hanifin and Rajka AD
- The severity of SCORAD (SCORing Atopic Dermatitis) is 25-50 points.
Who cannot join
- Other eczema-like diseases that are not atopic dermatitis, such as contact dermatitis, seborrheic dermatitis, drug reactions, etc., shall be determined by a dermatologist.
- Associated with other skin diseases that may cause itching, as determined by a dermatologist.
- Have bacterial infection or are using oral or injectable western medicines such as steroids, antibiotics, leukotriene antagonists and other immunosuppressants; as well as using phototherapy, immunotherapy, hyposensitivity therapy; full month.
- Those who cannot cooperate with taking the medicine on time. Those who are unable to cooperate with filling out the questionnaire, drawing blood, and leaving stool samples.
- Those who have a history of allergy to fucoidan or have had adverse reactions and hyperthyroidism.
- Severe organ dysfunction, such as impaired renal and hepatic function at the time of initial diagnosis (including chronic kidney disease stage III, IV, V and AST, ALT ≥ 3 times the upper limit of normal), cirrhosis or heart failure, by clinician determination.
- Uncontrollable mental problems or other serious systemic diseases.
- Pregnant or breastfeeding women and all women of childbearing age who do not agree to take appropriate contraceptive measures.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan
Sien-hung Yang, Ph.D., +886-3-3196200 ext. 2611, dryang@ms1.hinet.net
About this study
Official title: Study of the Effects on the Gut Microbiota in the Patients of Atopic Dermatitis Before and After the Treatment of Fucoidan.
Forty patients with physician-identified atopic dermatitis will be enrolled in the study. All patients must be aged between 6 and 60 years old. All patients consumed fucoidan for 3 months.
Read the detailed description
Atopic dermatitis is an inflammatory disease with about 6-7% in Taiwan. Its clinical manifestations are repeated rashes and itching of the skin. The patient's skin is stimulated to release inflammatory precursor substances, causing the vascular endothelium to produce adhesion molecules to increase the exudation of inflammatory precursor substances and inflammatory cells to the skin of the lesion; it also triggers the differentiation of Th0 in the skin and blood of the lesion into Th2. Th2 further induced increased serum IgE concentration and increased eosinophilia. At the same time, the non-affected skin will further cultivate more Th2 through leukocytes expressing IgE to enhance the allergic response in the acute phase. Studies show that it is related to the increase of TNF-α. The skin in the chronic phase is mainly manifested by dendritic cells, macrophages, eosinophils, and IL-12. An environment rich in these inflammatory cells and substances allows Th0 to differentiate into Th1 and induces IFN-γ expression, resulting in tissue remodeling, thickening, and desquamation of the epidermis (mossy lesions).
Current treatments for atopic dermatitis include moisturizing agents, antipruritic drugs (such as oral antihistamines), oral and topical steroids, immunomodulators, light therapy, and antibiotic therapy for infections. External use of steroid ointments can easily atrophy the skin and is not recommended for long-term use. Although oral antihistamines can relieve itching, they have the side effect of drowsiness, which can cause an inability to concentrate and trance. In addition, the long-term use of oral steroids has excellent side effects on the endocrine and so on, and it is not suitable for use during infection.
Intestinal bacteria have many effects on the human body, including nutrient absorption, the formation of vitamins and hormones, and the prevention of the formation of pathological colonies. In recent years, the research on the impact of intestinal bacteria on human immune function has become more and more understood. Immunity effects include Segmented filamentous bacteria that promote the differentiation of Th17 and Clostridium spp. that promote the development of regulatory T cells. At the same time, researchers have also found that many diseases, including allergies, asthma, diabetes, obesity, tumors, and neuropathy, may be related to intestinal bacteria. Hothe investigatorsver, whether fucoidan will affect the colony changes in the human gut after taking it has not yet been studied. Our past research discussed that fucoidan could improve atopic dermatitis with immunomodulatory effects, and whether it is related to changes in gut bacteria is unknown.
Purpose:
This study hopes to understand whether improving symptoms in patients with atopic dermatitis by fucoidan is related to intestinal flora change.
Therefore, this prospective trial's results are designed to understand further fucoidan consumption's effect on atopic dermatitis-the effects of gut bacteria in patients.
At the same time, the clinical effect of fucoidan on patients with atopic dermatitis can be tested again.
Specimen collection and testing:
The investigators will get twice stool specimens and blood draw, about 5 c.c. each time, at the beginning and end of the study (at the tthe investigatorslfth the investigatorsek.)
- Conditions
- Atopic Dermatitis
- Being tested
- Fucoidan
- Keywords
- atopic dermatitis, Fucoidan, Gut microbiota
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FucoidanDietary supplement
All patients consumed fucoidan.
| Study group | Role | What they receive |
|---|---|---|
| Fucoidan | Experimental | All patients are in the experimental group. Receives: Dietary Supplement: Fucoidan |
What is being measured
The primary outcome is the main question the study is designed to answer.
collect cecal stool for DNA purification and quantitative PCR for analysis of gut microbiota
Changes in gut bacteria before and after consumption of natural small molecule fucoidan in patients with atopic dermatitis.
- Cecal stool DNA purification
- Quantification of cecal microbiota by quantitative PCR (qPCR)
- V3-V5 16S rRNA amplification
Measured: Assessment of gut microbiota on Day 0 and 3 month after completing treatment
Secondary outcomes (1)
Use SCORAD index to measure the severity and extent of skin rash, itching, and sleep disturbance
Evaluation of clinical symptoms such as the severity and extent of skin rash, itching, improvement in quality of life and sleep, and the relationship between the reduction in the use of western medicines and changes in intestinal flora by SCORAD index.
Subjects were required to return for 3 visits. During these 3 outpatient visits, subjects will be asked questions about atopic dermatitis and photographed and recorded.
Measured: Assessment on Day 0 and 3 month after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start4 Oct 2022
- Primary completion6 Mar 2024 (estimated)
- Study completion6 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YANG SIEN-HUNG, Chang Gung Memorial Hospital
- Investigators
- Sien-hung Yang, Ph.D., Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437887
- Sponsor's protocol ID
- 202200413A3
- Status last verified
- Dec 2022
- First submitted
- 14 Jun 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects on the Gut Microbiota in the Patients of Atopic Dermatitis Before and After the Treatment of Fucoidan.
- ClinicalTrials.gov ID
- NCT05437887
- Acronym / sponsor ID
- 202200413A3
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, Fucoidan, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 6 Mar 2024 (estimated)
- Study completion
- 6 Mar 2024 (estimated)
- First posted
- 29 Jun 2022 (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.
Forty patients with physician-identified atopic dermatitis will be enrolled in the study. All patients must be aged between 6 and 60 years old. All patients consumed fucoidan for 3 months.
Detailed description
Atopic dermatitis is an inflammatory disease with about 6-7% in Taiwan. Its clinical manifestations are repeated rashes and itching of the skin. The patient's skin is stimulated to release inflammatory precursor substances, causing the vascular endothelium to produce adhesion molecules to increase the exudation of inflammatory precursor substances and inflammatory cells to the skin of the lesion; it also triggers the differentiation of Th0 in the skin and blood of the lesion into Th2. Th2 further induced increased serum IgE concentration and increased eosinophilia. At the same time, the non-affected skin will further cultivate more Th2 through leukocytes expressing IgE to enhance the allergic response in the acute phase. Studies show that it is related to the increase of TNF-α. The skin in the chronic phase is mainly manifested by dendritic cells, macrophages, eosinophils, and IL-12. An environment rich in these inflammatory cells and substances allows Th0 to differentiate into Th1 and induces IFN-γ expression, resulting in tissue remodeling, thickening, and desquamation of the epidermis (mossy lesions).
Current treatments for atopic dermatitis include moisturizing agents, antipruritic drugs (such as oral antihistamines), oral and topical steroids, immunomodulators, light therapy, and antibiotic therapy for infections. External use of steroid ointments can easily atrophy the skin and is not recommended for long-term use. Although oral antihistamines can relieve itching, they have the side effect of drowsiness, which can cause an inability to concentrate and trance. In addition, the long-term use of oral steroids has excellent side effects on the endocrine and so on, and it is not suitable for use during infection.
Intestinal bacteria have many effects on the human body, including nutrient absorption, the formation of vitamins and hormones, and the prevention of the formation of pathological colonies. In recent years, the research on the impact of intestinal bacteria on human immune function has become more and more understood. Immunity effects include Segmented filamentous bacteria that promote the differentiation of Th17 and Clostridium spp. that promote the development of regulatory T cells. At the same time, researchers have also found that many diseases, including allergies, asthma, diabetes, obesity, tumors, and neuropathy, may be related to intestinal bacteria. Hothe investigatorsver, whether fucoidan will affect the colony changes in the human gut after taking it has not yet been studied. Our past research discussed that fucoidan could improve atopic dermatitis with immunomodulatory effects, and whether it is related to changes in gut bacteria is unknown.
Purpose:
This study hopes to understand whether improving symptoms in patients with atopic dermatitis by fucoidan is related to intestinal flora change.
Therefore, this prospective trial's results are designed to understand further fucoidan consumption's effect on atopic dermatitis-the effects of gut bacteria in patients.
At the same time, the clinical effect of fucoidan on patients with atopic dermatitis can be tested again.
Specimen collection and testing:
The investigators will get twice stool specimens and blood draw, about 5 c.c. each time, at the beginning and end of the study (at the tthe investigatorslfth the investigatorsek.)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fucoidan | Experimental | Dietary Supplement: FucoidanAll patients are in the experimental group. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Volunteer for study enrollment and sign inform consent
- The age of the patients must be between 6 and 60 years old. Both men and women can participate.
- Symptoms meet the diagnostic criteria of Hanifin and Rajka AD
- The severity of SCORAD (SCORing Atopic Dermatitis) is 25-50 points.
Key exclusion criteria (8 listed)
- Other eczema-like diseases that are not atopic dermatitis, such as contact dermatitis, seborrheic dermatitis, drug reactions, etc., shall be determined by a dermatologist.
- Associated with other skin diseases that may cause itching, as determined by a dermatologist.
- Have bacterial infection or are using oral or injectable western medicines such as steroids, antibiotics, leukotriene antagonists and other immunosuppressants; as well as using phototherapy, immunotherapy, hyposensitivity therapy; full month.
- Those who cannot cooperate with taking the medicine on time. Those who are unable to cooperate with filling out the questionnaire, drawing blood, and leaving stool samples.
- Those who have a history of allergy to fucoidan or have had adverse reactions and hyperthyroidism.
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 |
|---|---|---|
| FucoidanAll patients consumed fucoidan. | Dietary supplement | Fucoidan |
Primary outcome
collect cecal stool for DNA purification and quantitative PCR for analysis of gut microbiota
Time frame: Assessment of gut microbiota on Day 0 and 3 month after completing treatment
Changes in gut bacteria before and after consumption of natural small molecule fucoidan in patients with atopic dermatitis. 1. Cecal stool DNA purification 2. Quantification of cecal microbiota by quantitative PCR (qPCR) 3. V3-V5 16S rRNA amplification
1 secondary outcome
Use SCORAD index to measure the severity and extent of skin rash, itching, and sleep disturbance
Time frame: Assessment on Day 0 and 3 month after completing treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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. This study is not recruiting at the moment.
Sien-hung Yang, Ph.D. study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fucoidan in people with Atopic Dermatitis, run by Chang Gung Memorial Hospital at 1 site 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sien-hung Yang, Ph.D. (+886-3-3196200 ext. 2611, dryang@ms1.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect cecal stool for DNA purification and quantitative PCR for analysis of gut microbiota (time frame: Assessment of gut microbiota on Day 0 and 3 month after completing treatment). 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 6 Dec 2022.