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

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema
• Interventions: Dietary Supplement: Lactic acid bacteria NTU 101; Dietary Supplement: Placebo

• Registration Number: NCT05719649
• Lead Sponsor: SunWay Biotech Co., LTD.

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-30
• Status Verified: 2023-02
• Study First Posted: 2023-02-09
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02
• Study Start: 2023-04-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic NTU 101 Lactic Acid Bacteria Capsules	Lactic acid bacteria NTU 101	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 (1.8 x 10 \^10 CFU) 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.
Placebo Capsules	Placebo	Maltodextrin was used as a placebo.

Primary Outcome Measures

Name	Time	Method
SCORing Atopic Dermatitis (SCORAD) Improvement Total Score	12 weeks	Compared with the placebo group, after taking probiotics or placebo for 4, 8, and 12 weeks, the atopic dermatitis severity score SCORAD in the control group improved by at least 30% or the ratio of subjects in the test group to the placebo groupPlacebo group According to the statistical method, there is a statistical difference in the total score of SCORAD improvement, at least reaching one of the two items.