NCT05719649

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: SunWay Biotech Co., LTD. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactic acid bacteria NTU 101	One NTU 101 Lactic Acid Bacteria Vegetable Capsule a day for a total of 12 weeks. Product ingredients: microcrystalline cellulose, corn starch, NTU 101 Lactobacillus paracasei subsp. paracasei NTU 101 (1.8 x 10\^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
DIETARY_SUPPLEMENT	Placebo	Maltodextrin was used as a placebo

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-05-01
• Completion: 2023-05-14
• First posted: 2023-02-09
• Last updated: 2023-03-02