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

NCT05719649 | Unknown DMC

• 2 other identifiers: 21 NTU 101N202211025
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

Probiotic NTU 101 Lactic Acid Bacteria Capsules

EXPERIMENTAL

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.

Dietary Supplement: Lactic acid bacteria NTU 101

Placebo Capsules

PLACEBO COMPARATOR

Maltodextrin was used as a placebo.

Dietary Supplement: Placebo

Interventions

Lactic acid bacteria NTU 101 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.

Probiotic NTU 101 Lactic Acid Bacteria Capsules

Placebo DIETARY_SUPPLEMENT

Maltodextrin was used as a placebo

Placebo Capsules

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SunWay Biotech Co., LTD.: lead

Related Publications (31)

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MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Woan-Ruoh Lee, Ph. D.

  Director of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Lin

CONTACT

02-27929568; sean.lin@sunway.cc

Nina Chen

CONTACT

02-2249-0088; hellonina18@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: With the random assignment system of Taipei Medical University, 6 Blocks, double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 9, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 14, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share