Mushroom extract tested to stop lung infection relapse
NCT ID NCT07174076
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether a daily cordyceps sinensis capsule (Bailiing Capsule) can prevent the recurrence of Mycobacterium avium complex (MAC) lung disease in adults who have already been cured. 300 participants will take either the cordyceps capsule or a placebo for 12 months, with regular checkups every 3 months. The main goal is to see if the supplement reduces bacterial recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cordyceps sinensis capsule (Bailiing Capsule)
- What this could lead to
- If it works, this could offer a natural supplement to help prevent MAC lung disease from coming back after successful treatment.
- What could go wrong
- This is a Phase 4 trial, but it's still early to know if cordyceps is effective. The study uses a placebo, so results may show no benefit. Also, supplements can have side effects or interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Chest Hospital
RECRUITINGHefei, Anhui, China
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Beijing Chest Hospital, Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
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China-Japan Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Guangzhou Chest Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Jiangxi Chest Hospital
RECRUITINGNanchang, Jiangxi, China
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Shanghai Pulmonary Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, China
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