Long-term oral Staphylococcus albicans tablets for bronchiectasis
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
NA · Qianfoshan Hospital · NCT05407792
This study is testing if taking Staphylococcus albicans tablets for a long time can help people with bronchiectasis have fewer flare-ups and improve their overall well-being.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05407792 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of long-term oral administration of Staphylococcus albicans tablets in patients with bronchiectasis. The primary goal is to determine if these tablets can significantly reduce the frequency of acute exacerbations and the risk of hospitalization, while also improving patients' quality of life. The study will also explore the potential effects of these tablets on the immune function of patients. Participants will include those diagnosed with bronchiectasis who have experienced multiple exacerbations in the past year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of bronchiectasis and a history of at least two acute exacerbations in the past year.
Not a fit: Patients with cystic fibrosis, severe immunodeficiency, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to fewer acute exacerbations and improved quality of life for patients with bronchiectasis.
How similar studies have performed: There is limited clinical evidence supporting the efficacy of similar approaches, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Where this trial is running
Jinan, Shandong
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchiectasis