Long-term oral Staphylococcus albicans tablets for bronchiectasis
Official title: 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
Run by Qianfoshan Hospital · NCT05407792 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | June 6, 2022 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 28, 2025 |
| Trial ID | NCT05407792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with cystic fibrosis, severe immunodeficiency, or other significant comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: There is limited clinical evidence supporting the efficacy of similar approaches, making this study a novel investigation.
Who can join: the full rules
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 it's running
-
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Chronic Respiratory Disease Participant Engagement
This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.
-
Breathlessness in respiratory diseases: who feels it and why
This study tests how physiology, psychology, function, and breathing patterns relate to breathlessness in people with respiratory conditions compared with healthy controls.
-
Hypertonic saline inhalation for NTM lung disease
This trial tests whether starting inhaled 3% hypertonic saline early helps people with non-tuberculous mycobacterial lung disease feel better and clear bacteria better, compared with starting with normal saline first.
-
Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups
This trial tests whether taking azithromycin daily for a year reduces bronchiectasis-related flare-ups in adults with non-cystic fibrosis bronchiectasis.
-
Bronchiectasis Phenotype Identification Model for Adults
This study tests a baseline classifier to categorize adults with non-cystic fibrosis bronchiectasis into phenotype groups using data collected over time.
-
BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups
This study tests a new BASE framework to classify how severe non-cystic fibrosis bronchiectasis is right now and see if it can predict 12 months of worsening or flare-ups.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.