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Status unknownNCT05437887Updated Dec 6, 2022

Effects of Fucoidan on the Gut Microbiota in the Patients of Atopic Dermatitis

An interventional study of Fucoidan in Atopic Dermatitis, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 6 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
6 Years to 60 Years
Sex
All
01

Study 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 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.)

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • atopic dermatitis
  • Fucoidan
  • Gut microbiota
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 40 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Fucoidan

    All patients are in the experimental group.

    Dietary Supplement: Fucoidan

Interventions

  • Dietary supplementFucoidan

    All patients consumed fucoidan.

06

What researchers measure

Primary outcomes

  1. 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. 1. Cecal stool DNA purification 2. Quantification of cecal microbiota by quantitative PCR (qPCR) 3. V3-V5 16S rRNA amplification

    Time frame: 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.

    Time frame: Assessment on Day 0 and 3 month after completing treatment

07

Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital
    Taoyuan, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05437887
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
YANG SIEN-HUNG (Director of Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital) — Principal investigator
First posted
Jun 29, 2022
Start date
Oct 4, 2022
Primary completion
Mar 6, 2024 (estimated)
Completion
Mar 6, 2024 (estimated)
Last update
Dec 6, 2022

Study contacts

Sien-hung Yang, Ph.D.
Contact
dryang@ms1.hinet.net
+886-3-3196200 ext. 2611
Sien-hung Yang, Ph.D.
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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