The Efficacy of NTU 101 Lactic Acid Bacteria Powder in the Adjuvant Improvement of Atopic Dermatitis Clinical Trial
NCT ID: NCT05719649
Last Updated: 2023-03-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
72 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-04-01
Study Completion Date
2023-05-14
Brief Summary
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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)
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Detailed Description
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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.
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
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Atopic Dermatitis
Atopic Dermatitis Eczema
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
With the random assignment system of Taipei Medical University, 6 Blocks, double-blind
Study Groups
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Probiotic NTU 101 Lactic Acid Bacteria Capsules
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.
Group Type
EXPERIMENTAL
Lactic acid bacteria NTU 101
Intervention Type
DIETARY_SUPPLEMENT
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.
Placebo Capsules
Maltodextrin was used as a placebo.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DIETARY_SUPPLEMENT
Maltodextrin was used as a placebo
Interventions
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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.
Intervention Type
DIETARY_SUPPLEMENT
Placebo
Maltodextrin was used as a placebo
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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
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.
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.
Minimum Eligible Age
6 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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SunWay Biotech Co., LTD.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Woan-Ruoh Lee, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Director of Dermatology
Central Contacts
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References
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Leung DY, Boguniewicz M, Howell MD, Nomura I, Hamid QA. New insights into atopic dermatitis. J Clin Invest. 2004 Mar;113(5):651-7. doi: 10.1172/JCI21060.
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Reddel S, Del Chierico F, Quagliariello A, Giancristoforo S, Vernocchi P, Russo A, Fiocchi A, Rossi P, Putignani L, El Hachem M. Gut microbiota profile in children affected by atopic dermatitis and evaluation of intestinal persistence of a probiotic mixture. Sci Rep. 2019 Mar 21;9(1):4996. doi: 10.1038/s41598-019-41149-6.
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Czarnowicki T, Santamaria-Babi LF, Guttman-Yassky E. Circulating CLA+ T cells in atopic dermatitis and their possible role as peripheral biomarkers. Allergy. 2017 Mar;72(3):366-372. doi: 10.1111/all.13080. Epub 2016 Dec 15.
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RESULT
Ferran M, Romeu ER, Rincon C, Sagrista M, Gimenez Arnau AM, Celada A, Pujol RM, Hollo P, Jokai H, Santamaria-Babi LF. Circulating CLA+ T lymphocytes as peripheral cell biomarkers in T-cell-mediated skin diseases. Exp Dermatol. 2013 Jul;22(7):439-42. doi: 10.1111/exd.12154.
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RESULT
Czarnowicki T, Esaki H, Gonzalez J, Malajian D, Shemer A, Noda S, Talasila S, Berry A, Gray J, Becker L, Estrada Y, Xu H, Zheng X, Suarez-Farinas M, Krueger JG, Paller AS, Guttman-Yassky E. Early pediatric atopic dermatitis shows only a cutaneous lymphocyte antigen (CLA)(+) TH2/TH1 cell imbalance, whereas adults acquire CLA(+) TH22/TC22 cell subsets. J Allergy Clin Immunol. 2015 Oct;136(4):941-951.e3. doi: 10.1016/j.jaci.2015.05.049. Epub 2015 Aug 1.
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Vernocchi P, Del Chierico F, Fiocchi AG, El Hachem M, Dallapiccola B, Rossi P, Putignani L. Understanding probiotics' role in allergic children: the clue of gut microbiota profiling. Curr Opin Allergy Clin Immunol. 2015 Oct;15(5):495-503. doi: 10.1097/ACI.0000000000000203.
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Other Identifiers
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N202211025
Identifier Type: OTHER
Identifier Source: secondary_id
21 NTU 101
Identifier Type: -
Identifier Source: org_study_id
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