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

Primary Purpose

Atopic Dermatitis, Atopic Dermatitis Eczema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactic acid bacteria NTU 101
Placebo
Sponsored by
SunWay Biotech Co., LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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 old Patients with moderate atopic dermatitis: SCORAD index 25 - 49.9 (moderate). Atopic dermatitis diagnosed over 6 months Exclusion 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotic NTU 101 Lactic Acid Bacteria Capsules

    Placebo Capsules

    Arm Description

    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.

    Maltodextrin was used as a placebo.

    Outcomes

    Primary Outcome Measures

    SCORing Atopic Dermatitis (SCORAD) Improvement Total Score
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 10, 2023
    Last Updated
    February 28, 2023
    Sponsor
    SunWay Biotech Co., LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05719649
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2023 (Anticipated)
    Study Completion Date
    May 14, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SunWay Biotech Co., LTD.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis, Atopic Dermatitis Eczema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantCare Provider
    Masking Description
    With the random assignment system of Taipei Medical University, 6 Blocks, double-blind
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic NTU 101 Lactic Acid Bacteria Capsules
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Capsules
    Arm Type
    Placebo Comparator
    Arm Description
    Maltodextrin was used as a placebo.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactic acid bacteria NTU 101
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Maltodextrin was used as a placebo
    Primary Outcome Measure Information:
    Title
    SCORing Atopic Dermatitis (SCORAD) Improvement Total Score
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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 old Patients with moderate atopic dermatitis: SCORAD index 25 - 49.9 (moderate). Atopic dermatitis diagnosed over 6 months Exclusion 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Lin
    Phone
    02-27929568
    Ext
    612
    Email
    sean.lin@sunway.cc
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nina Chen
    Phone
    02-2249-0088
    Ext
    1157
    Email
    hellonina18@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Woan-Ruoh Lee, Ph. D.
    Organizational Affiliation
    Director of Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    The Efficacy of NTU 101 Lactic Acid Bacteria Powder in the Adjuvant Improvement of Atopic Dermatitis Clinical Trial

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