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Not Yet Recruiting NCT05719649

The Efficacy of NTU 101 Lactic Acid Bacteria Powder in the Adjuvant Improvement of Atopic Dermatitis Clinical Trial

Conditions: Atopic Dermatitis, Atopic Dermatitis Eczema

Sex: All
Ages: 6 Years – 12 Years
Phase: NA
Enrollment: 72
Sponsor: SunWay Biotech Co., LTD.

Summary

This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)

Eligibility Criteria

Inclusion Criteria:- According to the diagnostic criteria of Hanifin & Rajka atopic dermatitis, patients with clinical diagnosis of atopic dermatitis were screened and those who met the following conditions:Age: Children over 6 years old and under 12 years oldPatients with moderate atopic dermatitis: SCORAD index 25 - 49.9 (moderate).Atopic dermatitis diagnosed over 6 monthsExclusion Criteria:Immunodeficiency:Congenital immunodeficiency: According to the classification principle of "Current classification and status of primary immunodeficiency diseases in Taiwan", it is divided into (1) cellular/T-cell immunodeficiency (2) humoral immunodeficiency (Humoral/B- (3) Complement deficiency (4) Phagocyte deficiency.Human immunodeficiency virus (Human Immunodeficiency Virus, HIV) infection (Inquired from medical records).Other diseases that affect immune function, including kidney disease, diabetes, liver cirrhosis and chronic liver disease, asplenia.Short Bowel Syndrome (Short Bowel Syndrome).Patients with malignant tumors.Patients with central venous catheters.Secondary bacterial infection.Received immunosuppressive and biological agents in the past 3 months (eg: dupilumab, Janus kinase (JAK) inhibitors, Janus kinase inhibitors).Received oral or injectable steroids, antibiotics, and light therapy in the past 1 month.Continuously (3 days or more) take Chinese herbal medicine, probiotic supplements or other fermented foods, such as yogurt, yogurt, and Yakult.Abnormal liver or kidney function (1.5 times higher than normal).Other skin diseases or other systemic diseases.Participated in other clinical trials in the past 3 months.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05719649). StuddyBuddy aggregates publicly available trial information.