Preventing MAC lung disease from coming back with Cordyceps sinensis capsules

Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease

This trial will test whether taking a daily Cordyceps sinensis (Bailiing) capsule for 12 months can prevent recurrence of Mycobacterium avium complex (MAC) lung disease in adults who have been microbiologically cured.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Hefei, Anhui and 5 other locations)
• Trial ID: NCT07174076 on ClinicalTrials.gov

What this trial studies

Adults who completed recommended antibiotic treatment for nodular‑bronchiectatic MAC and achieved two consecutive negative sputum cultures are randomized to take either Cordyceps sinensis capsules or a matching placebo daily for 12 months. Participants attend clinic visits every three months for checks and testing and complete monthly online questionnaires. The main outcome is whether the supplement reduces microbiologic recurrence of MAC after cure. The trial is an investigator‑led, phase 4, multicenter study conducted at several chest hospitals in China.

Who should consider this trial

Good fit: Adults aged 18–75 who have completed recommended macrolide+ethambutol+rifampin therapy for nodular‑bronchiectatic MAC, achieved bacteriologic negativity (two consecutive negative sputum cultures ≥4 weeks apart), and can attend regular visits are ideal candidates.

Not a fit: Patients who have not achieved microbiologic cure, have a different MAC disease pattern (for example fibrocavitary disease), are unable to take the study medication or comply with follow‑up, or who are pregnant are unlikely to benefit from this trial.

Why it matters

Potential benefit: If effective, this could reduce how often MAC lung disease comes back after standard antibiotic cure, potentially lowering the need for retreatment.

How similar studies have performed: Use of Cordyceps sinensis to prevent MAC recurrence is largely novel with limited clinical evidence supporting its effectiveness for this specific purpose.

Eligibility criteria

Inclusion Criteria:

1. Patients voluntarily participate in the study and sign the informed consent form.
2. Age between 18 and 75 years, inclusive; gender unrestricted.
3. Confirmed diagnosis of MAC (Mycobacterium avium complex) lung disease according to either the 2020 ATS/IDSA guidelines or the Chinese Guideline for Diagnosis and Treatment of Nontuberculous Mycobacterial Disease (2020 edition). Imaging findings at baseline must show a nodular bronchiectatic pattern prior to treatment initiation.
4. Completed the recommended treatment regimen for nodular-bronchiectatic MAC lung disease (macrolide + ethambutol + rifampin, with minimum 12-month duration) per the above guidelines within 3 months prior to screening; Fully completed the anti-infective treatment phase of this study. Participants must achieve bacteriologic negativity (two consecutive negative sputum cultures with an interval ≥4 weeks) by the end of their treatment course.
5. For non-surgically sterilized women of childbearing potential:

   Must use a medically approved contraceptive method (e.g., intrauterine device, hormonal contraceptives, or condoms) during the study period and for 3 months post-last treatment dose. A negative serum/urine pregnancy test must be confirmed within 72 hours prior to enrollment.

   Must not be lactating at screening.

   For male participants with partners of childbearing potential:

   Must use effective contraception during the study and for 3 months post-last treatment dose.
6. Organ Function Requirements (Met Within 1 Week Prior to Enrollment):

i. Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3× upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3× ULN; vi. Alanine aminotransferase (ALT) ≤3× ULN; vii. Serum creatinine \<2× ULN or creatinine clearance ≥60 mL/min; viii. Blood urea nitrogen (BUN) ≤200 mg/L; ix. Urine protein \<++ on dipstick; if trace (+), 24-hour urine protein must be \<500 mg; x. Fasting glucose within normal range \*\*or\*\* controlled stable glycemic levels in diabetic patients; xi. Cardiac function: No myocardial infarction in the past 6 months, no unstable angina, no severe arrhythmias, and New York Heart Association (NYHA) functional class ≤II.

Exclusion Criteria:

1. Any allergy to drugs included in the treatment regimen.
2. Completed anti-MAC therapy for more than 3 months.
3. Active respiratory tract infection.
4. Presence of congenital/acquired immunodeficiency diseases, active pulmonary malignancies (primary or metastatic), or any malignant tumors requiring chemotherapy/radiotherapy during screening or the study period.
5. History of solid organ transplantation.
6. Currently undergoing dialysis.
7. Radiographic pneumonia requiring steroid/immunoglobulin pulse therapy, clinically evident active interstitial lung disease, uncontrolled massive pleural effusion/pericardial effusion.
8. Unstable concomitant systemic diseases (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic/renal dysfunction, neurodegenerative diseases such as Alzheimer's disease).
9. Poor gastrointestinal function or malabsorption syndrome.
10. Receipt of other investigational drugs (excluding participation of 2025-KY-004-1) within 4 weeks prior to the first administration of study drug.
11. Participation in another interventional clinical trial simultaneously, except for observational/non-interventional trials or follow-up periods of interventional trials.
12. Any physical examination findings or clinical laboratory results that the investigator believes may interfere with study outcomes or pose increased risks of complications for the patient's management.

Where this trial is running

Hefei, Anhui and 5 other locations

• Anhui Chest Hospital — Hefei, Anhui, China (Recruiting)
• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Guangzhou Chest Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Jiangxi Chest Hospital — Nanchang, Jiangxi, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Xiaojing Cui, M.D. — China-Japan Friendship Hospital
• Study coordinator: Siwei Gu, M.D.

Conditions Mycobacterium Avium Complex Pulmonary Disease; mycobacerium avium complex; recurrence; cordyceps sinesis