The effect of Bailing (Cordyceps sinesis) capsule in preventing recurrence of mycobacterium avium complex pulmonary disease: a protocol of multicenter, randomized, double-blind, placebo-controlled trial

Mycobacterium avium complex pulmonary disease (MAC-PD) is a chronic infectious disease characterized by a high rate of recurrence. No previous study has examined the efficacy of traditional Chinese medicine (TCM) on reducing MAC-PD recurrence. Bailing capsule ( Bailing ) is effective in treating chronic bronchitis and chronic obstructive pulmonary disease. Previous studies have proved its immunomodulatory effects and might be effective for preventing the recurrence of MAC-PD. This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial with parallel design. 300 participants with microbiologically cured MAC-PD will be recruited and randomly assigned to either Bailing group or placebo group in a ratio of 1:1. Both Bailing and placebo will be administered 4 capsules, three times per day orally for 12 consecutive months with monthly follow-ups including quality of life questionnaire, blood analysis and radiologic examinations. The primary outcome is the rate of MAC-PD recurrence within 12 months, detected by mycobacteria culture or sequencing. Secondary outcomes include time-to-recurrence, the rate of other respiratory tract infections, quality of life, respiratory symptoms and adverse events. This trial is the first to prospectively evaluate the effect of a specific intervention in reducing the recurrence of MAC-PD. The rigid design and large sample size further boost the power of this trial. Through this study, we hope to establish TCM as a host-directed therapy in the long-term management of chronic infectious disease. Further research will be made to evaluate the optimal duration of treatment. NCT07174076.