NCT05437887

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

1.4 years

First QC Date

June 14, 2022

Last Update Submit

December 4, 2022

Conditions

Atopic Dermatitis

Keywords

atopic dermatitisFucoidanGut microbiota

Outcome Measures

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

    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

    Assessment on Day 0 and 3 month after completing treatment

Study Arms (1)

Fucoidan

EXPERIMENTAL

All patients are in the experimental group.

Dietary Supplement: Fucoidan

Interventions

FucoidanDIETARY_SUPPLEMENT

All patients consumed fucoidan.

Fucoidan

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

fucoidan

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sien-hung Yang, Ph.D.

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Sien-hung Yang, Ph.D.

CONTACT

+886-3-3196200dryang@ms1.hinet.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Traditional Chinese Medicine

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 29, 2022

Study Start

October 4, 2022

Primary Completion

March 6, 2024

Study Completion

March 6, 2024

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)