Status:
RECRUITING
Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis
Lead Sponsor:
Qianfoshan Hospital
Conditions:
Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 br...
Detailed Description
Bronchiectasis is a chronic airway purulent disease. The four factors of "vicious circle" play an important role in the occurrence, development and prognosis of bronchiectasis. Attempts to breaks the ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05407792
Start Date
June 6 2022
End Date
December 31 2026
Last Update
February 28 2025
Active Locations (1)
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1
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250014