Atopic DermatitisNCT05719649
The Efficacy of NTU 101 Lactic Acid Bacteria Powder in the Adjuvant Improvement of Atopic Dermatitis Clinical Trial
A study testing Lactic acid bacteria NTU 101 in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by SunWay Biotech Co., LTD..
Trial 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) Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis Eczema
- What is being tested?
- Lactic acid bacteria NTU 101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 14 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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)
Read the 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
- Being tested
- Lactic acid bacteria NTU 101, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactic acid bacteria NTU 101Dietary 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.
PlaceboDietary supplement
Maltodextrin was used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Lactic acid bacteria NTU 101 |
| Placebo Capsules | Placebo comparator | Maltodextrin was used as a placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion14 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SunWay Biotech Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woan-Ruoh Lee, Ph. D., Principal investigator, Director of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719649
- Sponsor's protocol ID
- 21 NTU 101
- Other IDs
- N202211025
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Irvine AD, Mina-Osorio P. Disease trajectories in childhood atopic dermatitis: an update and practitioner's guide. Br J Dermatol. 2019 Nov;181(5):895-906. doi: 10.1111/bjd.17766. Epub 2019 May 15.
PubMed 30758843Doron S, Snydman DR. Risk and safety of probiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S129-34. doi: 10.1093/cid/civ085.
PubMed 25922398Zuntar I, Petric Z, Bursac Kovacevic D, Putnik P. Safety of Probiotics: Functional Fruit Beverages and Nutraceuticals. Foods. 2020 Jul 17;9(7):947. doi: 10.3390/foods9070947.
PubMed 32708933Leung 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.
PubMed 14991059Zheng T, Yu J, Oh MH, Zhu Z. The atopic march: progression from atopic dermatitis to allergic rhinitis and asthma. Allergy Asthma Immunol Res. 2011 Apr;3(2):67-73. doi: 10.4168/aair.2011.3.2.67. Epub 2011 Feb 14.
PubMed 21461244Kim J, Kim BE, Leung DYM. Pathophysiology of atopic dermatitis: Clinical implications. Allergy Asthma Proc. 2019 Mar 1;40(2):84-92. doi: 10.2500/aap.2019.40.4202.
PubMed 30819278Thyssen JP, Kezic S. Causes of epidermal filaggrin reduction and their role in the pathogenesis of atopic dermatitis. J Allergy Clin Immunol. 2014 Oct;134(4):792-9. doi: 10.1016/j.jaci.2014.06.014. Epub 2014 Jul 25.
PubMed 25065719McAleer MA, Irvine AD. The multifunctional role of filaggrin in allergic skin disease. J Allergy Clin Immunol. 2013 Feb;131(2):280-91. doi: 10.1016/j.jaci.2012.12.668.
PubMed 23374260Tsakok T, Woolf R, Smith CH, Weidinger S, Flohr C. Atopic dermatitis: the skin barrier and beyond. Br J Dermatol. 2019 Mar;180(3):464-474. doi: 10.1111/bjd.16934. Epub 2018 Oct 10.
PubMed 29969827Egawa G, Kabashima K. Barrier dysfunction in the skin allergy. Allergol Int. 2018 Jan;67(1):3-11. doi: 10.1016/j.alit.2017.10.002. Epub 2017 Nov 16.
PubMed 29153780Reddel 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.
PubMed 30899033Wakugawa M, Hayashi K, Nakamura K, Tamaki K. Evaluation of mite allergen-induced Th1 and Th2 cytokine secretion of peripheral blood mononuclear cells from atopic dermatitis patients: association between IL-13 and mite-specific IgE levels. J Dermatol Sci. 2001 Feb;25(2):116-26. doi: 10.1016/s0923-1811(00)00118-3.
PubMed 11164708Czarnowicki 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.
PubMed 27861978Ferran 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.
PubMed 23800052Czarnowicki 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.
PubMed 26242300
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05719649
- Acronym / sponsor ID
- 21 NTU 101
- Conditions
- Atopic Dermatitis, Atopic Dermatitis Eczema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- SunWay Biotech Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 14 May 2023 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic NTU 101 Lactic Acid Bacteria Capsules | Experimental | Dietary Supplement: Lactic acid bacteria NTU 101The 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 comparator | Dietary Supplement: PlaceboMaltodextrin was used as a placebo. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactic acid bacteria NTU 101One 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 | Probiotic NTU 101 Lactic Acid Bacteria Capsules |
| PlaceboMaltodextrin was used as a placebo | Dietary supplement | Placebo Capsules |
Primary outcome
SCORing Atopic Dermatitis (SCORAD) Improvement Total Score
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Results publication: PubMed 30758843Irvine AD, Mina-Osorio P. Disease trajectories in childhood atopic dermatitis: an update and practitioner's guide. Br J Dermatol. 2019 Nov;181(5):895-906. doi: 10.1111/bjd.17766. Epub 2019 May 15.
- Results publication: PubMed 25922398Doron S, Snydman DR. Risk and safety of probiotics. Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S129-34. doi: 10.1093/cid/civ085.
- Results publication: PubMed 32708933Zuntar I, Petric Z, Bursac Kovacevic D, Putnik P. Safety of Probiotics: Functional Fruit Beverages and Nutraceuticals. Foods. 2020 Jul 17;9(7):947. doi: 10.3390/foods9070947.
- Results publication: PubMed 14991059Leung 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.
- Results publication: PubMed 21461244Zheng T, Yu J, Oh MH, Zhu Z. The atopic march: progression from atopic dermatitis to allergic rhinitis and asthma. Allergy Asthma Immunol Res. 2011 Apr;3(2):67-73. doi: 10.4168/aair.2011.3.2.67. Epub 2011 Feb 14.
- Results publication: PubMed 30819278Kim J, Kim BE, Leung DYM. Pathophysiology of atopic dermatitis: Clinical implications. Allergy Asthma Proc. 2019 Mar 1;40(2):84-92. doi: 10.2500/aap.2019.40.4202.
- Results publication: PubMed 25065719Thyssen JP, Kezic S. Causes of epidermal filaggrin reduction and their role in the pathogenesis of atopic dermatitis. J Allergy Clin Immunol. 2014 Oct;134(4):792-9. doi: 10.1016/j.jaci.2014.06.014. Epub 2014 Jul 25.
- Results publication: PubMed 23374260McAleer MA, Irvine AD. The multifunctional role of filaggrin in allergic skin disease. J Allergy Clin Immunol. 2013 Feb;131(2):280-91. doi: 10.1016/j.jaci.2012.12.668.
- Results publication: PubMed 29969827Tsakok T, Woolf R, Smith CH, Weidinger S, Flohr C. Atopic dermatitis: the skin barrier and beyond. Br J Dermatol. 2019 Mar;180(3):464-474. doi: 10.1111/bjd.16934. Epub 2018 Oct 10.
- Results publication: PubMed 29153780Egawa G, Kabashima K. Barrier dysfunction in the skin allergy. Allergol Int. 2018 Jan;67(1):3-11. doi: 10.1016/j.alit.2017.10.002. Epub 2017 Nov 16.
- Results publication: PubMed 30899033Reddel 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.
- Results publication: PubMed 11164708Wakugawa M, Hayashi K, Nakamura K, Tamaki K. Evaluation of mite allergen-induced Th1 and Th2 cytokine secretion of peripheral blood mononuclear cells from atopic dermatitis patients: association between IL-13 and mite-specific IgE levels. J Dermatol Sci. 2001 Feb;25(2):116-26. doi: 10.1016/s0923-1811(00)00118-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woan-Ruoh Lee, Ph. D. principal investigator
Director of Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing Lactic acid bacteria NTU 101 in people with Atopic Dermatitis and Atopic Dermatitis Eczema, run by SunWay Biotech Co., LTD..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean Lin (02-27929568 ext. 612, sean.lin@sunway.cc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORing Atopic Dermatitis (SCORAD) Improvement Total Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719649, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.