Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05407792

Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis

Led by Qianfoshan Hospital · Updated on 2025-02-28

134

Participants Needed

1

Research Sites

238 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with bronchiectasis by clinical symptoms and chest HRCT
  • Patients with idiopathic or post-infectious bronchiectasis
  • Patients aged 18 years or older
  • Patients who had at least 2 acute exacerbations of bronchiectasis in the year before enrollment
  • Patients can be in either an acute exacerbation or stable phase at enrollment
Not Eligible

You will not qualify if you...

  • Diagnosis of cystic fibrosis
  • Immunodeficiency or allergic bronchopulmonary aspergillosis
  • Traction bronchiectasis caused by severe emphysema or advanced pulmonary fibrosis
  • Current smokers
  • Complicated with asthma or chronic obstructive pulmonary disease
  • Severe cardiovascular, neurological, liver, or kidney diseases
  • Malignant tumors
  • Allergy to Staphylococcus albicans tablets
  • History of gastric ulcer or intestinal malabsorption
  • Pregnant or lactating women
  • Poor compliance
  • Use of immunostimulating drugs or immunosuppressants within 6 months before study start
  • Participation in other interventional clinical trials within 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China, 250014

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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