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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fucoidan
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, Fucoidan, Gut microbiota

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fucoidan

Arm Description

All patients are in the experimental group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 14, 2022
Last Updated
December 4, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05437887
Brief Title
Effects of Fucoidan on the Gut Microbiota in the Patients of Atopic Dermatitis
Official Title
Study of the Effects on the Gut Microbiota in the Patients of Atopic Dermatitis Before and After the Treatment of Fucoidan.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
March 6, 2024 (Anticipated)
Study Completion Date
March 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, Fucoidan, Gut microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fucoidan
Arm Type
Experimental
Arm Description
All patients are in the experimental group.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fucoidan
Intervention Description
All patients consumed fucoidan.
Primary Outcome Measure Information:
Title
collect cecal stool for DNA purification and quantitative PCR for analysis of gut microbiota
Description
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
Time Frame
Assessment of gut microbiota on Day 0 and 3 month after completing treatment
Secondary Outcome Measure Information:
Title
Use SCORAD index to measure the severity and extent of skin rash, itching, and sleep disturbance
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sien-hung Yang, Ph.D.
Phone
+886-3-3196200
Ext
2611
Email
dryang@ms1.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sien-hung Yang, Ph.D.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sien-hung Yang, Ph.D.
Phone
+886-3-3196200
Ext
2611
Email
dryang@ms1.hinet.net

12. IPD Sharing Statement

Plan to Share IPD
No

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

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