Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis
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- Who runs it
- Qianfoshan Hospital
- Trial code
- NCT05407792
- Record updated
- 28 February 2025
- Original description
The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Secondary objective is to explore whether long-term oral administration of Staphylococcus albicans tablets can reduce the risk of hospitalization in patients with bronchiectasis and whether it can improve the quality of life of patients. Other purpose is to explore the regulatory effect of long-term oral administration of Staphylococcus albicans tablets on the immune function of patients with bronchiectasis.Read full original descriptionShow less
Efficacy and Safety of Long-term Oral Administration of Staphylococcus Albicans Tablets in Patients With Acute Exacerbation and Stable Bronchiectasis: a Multicenter, Prospective Randomized Controlled Clinical Trial
The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Secondary objective is to explore whether long-term oral administration of Staphylococcus albicans tablets can reduce the risk of hospitalization in patients with bronchiectasis and whether it can improve the quality of life of patients. Other purpose is to explore the regulatory effect of long-term oral administration of Staphylococcus albicans tablets on the immune function of patients with bronchiectasis.
Inclusion: Patients with bronchiectasis diagnosed by clinical manifestations and chest HRCT according to the diagnostic criteria for bronchiectasis; Patients with idiopathic or post-infectious bronchiectasis; 18years old; Patients should have at least 2 acute exacerbations within 1 year before enrollment; Patients in either acute exacerbation or stable period can be included.
Exclusion: Cystic fibrosis; Immunodeficiency, allergic bronchopulmonary aspergillosis, etc; Traction bronchiectasis caused by severe emphysema or advanced pulmonary fibrosis; Still smoking; Complicated with asthma or chronic obstructive disease Lung; Patients with severe cardiovascular disease, severe neurological disease, or severe liver or kidney damage; Malignant tumors; Allergy to Staphylococcus albicans tablets; Patients with a history of gastric ulcer or intestinal malabsorption; Pregnant or lactating women; patients with poor compliance; previous (within 6 months before the start of the study) or concurrently taking immunostimulating drugs (including thymosin, interferon, transfer factor, BCG, pneumonia vaccine and any kind of bacteria Extracts, such as Biostim, except for influenza vaccine) or immunosuppressants; Patients who are participating in or have participated in interventional clinical trials within 3 months.