Clinical trial NCT05719649: The Efficacy of NTU 101 Lactic Acid Bacteria Powder in the Adjuvant Improvement of Atopic Dermatitis Clinical Trial
Official title: The Efficacy of NTU 101 Lactic Acid Bacteria Powder in the Adjuvant Improvement of Atopic Dermatitis - A Double-blind, Multi-center Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Atopic Dermatitis Eczema
Lead sponsor: SunWay Biotech Co., LTD.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group: NTU 101 Lactobacillus Vegetable Capsules Product ingredients: microcrystalline cellulose, corn starch, NTU 101 lactic acid bacteria powder (1.8 x 10\^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), pure water, titanium dioxide, gellan gum.
Primary purpose: TREATMENT

Brief 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)

Detailed description: There is a screening period of about 2 weeks before the start of the test product. The subjects who meet the conditions of this test are randomly assigned according to the ratio of 1:1, and take the lactic acid bacteria NTU 101 or Placebo in the test group for a total of 12 weeks of treatment. Once, after the treatment, the test physician evaluated the safety and efficacy of the subjects taking the test group lactobacillus NTU 101 or Placebo.

After the end of the treatment period, all subjects underwent a 2-week discontinuation follow-up period.

This study will track subjects before and after taking samples, SCORing Atopic Dermatitis (Screen-Visit 4), Children's Dermatology Life Quality Index (Visit 1-Visit4), Patient-Oriented Eczema Measure (Visit 1-Visit4), to evaluate subjects Severity of illness.

The subjects received the following tests before and after taking the samples: a full set of blood tests, leukocyte differential counts, serum biochemical tests (BUN, Creatinine, GOT, GPT), and collection of peripheral blood mononuclear cells and stool samples for analysis of the subjects immune function and gastrointestinal microbiota.

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:

1. Age: Children over 6 years old and under 12 years old
2. Patients with moderate atopic dermatitis: SCORAD index 25 - 49.9 (moderate).
3. Atopic dermatitis diagnosed over 6 months

Exclusion Criteria:

1. 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.
2. Human immunodeficiency virus (Human Immunodeficiency Virus, HIV) infection (Inquired from medical records).
3. Other diseases that affect immune function, including kidney disease, diabetes, liver cirrhosis and chronic liver disease, asplenia.
4. Short Bowel Syndrome (Short Bowel Syndrome).
5. Patients with malignant tumors.
6. Patients with central venous catheters.
7. Secondary bacterial infection.
8. Received immunosuppressive and biological agents in the past 3 months (eg: dupilumab, Janus kinase (JAK) inhibitors, Janus kinase inhibitors).
9. Received oral or injectable steroids, antibiotics, and light therapy in the past 1 month.
10. Continuously (3 days or more) take Chinese herbal medicine, probiotic supplements or other fermented foods, such as yogurt, yogurt, and Yakult.
11. Abnormal liver or kidney function (1.5 times higher than normal).
12. Other skin diseases or other systemic diseases.
13. Participated in other clinical trials in the past 3 months.

Primary outcomes:
measure: SCORing Atopic Dermatitis (SCORAD) Improvement Total Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director of Dermatology
name: Woan-Ruoh Lee, Ph. D.
role: PRINCIPAL_INVESTIGATOR
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