None listed
Conditions
Interventions
Dietary Supplement : This Clinical Trial is an exploratory Clinical Trial planned to assess the validity and safety of auxiliary KBL693(Lactobacillus crispatus KBL693). The total number of subjects fo
Sponsors
Kobiolabs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 19 or older and under 75 years of age 2) A person who have been diagnosed with asthma for more than 12 months based on Visit 1 3) A person who has been using ICS(Inhaled Corticosteroid)+LABA(Long-Acting ß-Agonist) or ICS+LABA+LTRA(Leukotriene Receptor Antagonist) of low/medium/high capacity for more than two months based on visit 1 without changing capacity 4) A person whose FeNO(Fractional exhaled Nitric Oxide) exceeds 20 ppb or has a result value of 300 cells/µL or more in the blood within one month(30 days) based on Visit 1 5) A person whose score exceeds 1.5 points of ACQ-6(Asthma Control Questionnaire-6) 6) A person who exceed 40 percent of normal forecasts of FEV1(Forced Expiratory Volume in one second 1) 7) A person who has agreed to participate in this Clinical Trial before the commencement of the Clinical Trial and has signed a written Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) A person who smokes within six months based on visit 1 2) A person who has received airway intubation or mechanical breathing due to asthma, or who has been hospitalized for asthma attacks within six months based on visit 1 3) A person with chronic lung diseases (pulmonary emphysema, idiopathic pulmonary fibrosis, etc.) that may impair lung capacity 4) A person who has used biologics within six months based on visit 1 5) A person who has used alternative disease control agents (LAMA, Theophiline, etc.) within two months based on visit 1 6) A person who have received allergy immunotherapy within two months based on visit 1 7) A person who used whole-body steroids within four weeks based on visit 1 8) A person who used probiotics and antibiotics within two weeks based on visit 1 9) A person who has the metamorphosis of a malignant tumor that has been treated or untreated within five years based on visit 1(except for local basal cell carcinoma of the skin) 10) A person whose AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) exceeds 3x more than the normal upper limit of the study site 11) A person whose Creatinine exceeds 2x more than the normal upper limit of the study site 12) A person with severe cardiovascular disease(brain stroke, myocardial infarction, aortic aneurysm, etc.)(However, it is possible to participate in the test according to the judgment of the tester considering the condition of the person subject to the Clinical Trial) 13) A person with mental illness, such as schizophrenia, drug addiction, alcohol use disorders, and those who are being treated for depression 14) A person who is sensitive to or allergic to the main ingredients of investigatinal product 15) A person who is pregnant, breast-feeding, or planning to conceive within three months 16) A person who has participated in another clinical trial within four weeks based on visit 1 or plans to participate in another clinical trial since participation of this clinical trial 17) A person who the tester deems inappropriate for this clinical trial 18) A person who are judged by the tester to have failed to comply with asthma maintenance treatment 19) A person with less than 80% of compliance with Investigational product for screening purposes during the run-in period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score change of ACQ-6(Asthma Control Questionnaire-6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects less than 1 point of ACQ-6(Asthma Control Questionnaire-6);Score change of AQLQ(Asthma Quality of Life Questionnaire);Change in the lung capacity test (PEF(Peak Expiratory Flow), FEV1(Forced Expiratory Volume at 1 second), FVC(Forced Vital Capacity), FEV1/FVC ratio) values;Change in FeNO(Fractional concentration of exhaled Nitric Oxide) values;Maintenance status of ACQ-6 score, AQLQ score, Pulmonary function test values, FeNO values after 4 weeks of end of intake;Variation of blood, sputum, urine index and fecal microbiota | — |
Countries
Korea, Republic of
Contacts
Public ContactHyeon-jung Kim
Asan Medical Center
Outcome results
None listed