Ganoderma Spores Modulate the Gut-Brain Axis
Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial
Ling Zhiqiang
300 participants
Apr 11, 2026
INTERVENTIONAL
Conditions
Summary
This study aims to investigate whether Sporoderm-removed Ganoderma lucidum spore powder (RGLS) ameliorates depression in thyroid cancer patients through gut-brain axis modulation, and to elucidate the underlying microbial and metabolic mechanisms. This 3-month randomized, double-blind, placebo-controlled trial will enroll 300 postoperative papillary thyroid carcinoma patients with depressive symptoms (HAMD-24 ≥ 8). Participants will be randomly assigned(2 : 1) to receive RGLS (4 g/day) or matched placebo.
Eligibility
Inclusion Criteria5
- Outpatients at Zhejiang Cancer Hospital with histologically confirmed papillary thyroid carcinoma (post-surgery) and depressive symptoms (HAMD-24 score ≥ 8, confirmed by a clinical psychologist).
- Han Chinese ethnicity.
- No history of depression or other psychiatric disorders.
- Age 18-80 years.
- Female.
Exclusion Criteria10
- Suffering from other gastrointestinal system diseases.
- History of gastrointestinal surgery prior to intervention.
- Including those with other concurrent malignancies requiring chemotherapy, radiotherapy, biological therapy, or traditional Chinese medicine treatment.
- Received antibiotic treatment or microecological modulators within 3 months prior to intervention.
- Acute intestinal obstruction.
- Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant medication treatment.
- Organic brain diseases, brain trauma.
- History of psychiatric disorders, use of psychoactive substances (e.g., drugs).
- Severe liver or kidney dysfunction.
- Pregnancy or lactation.
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Interventions
From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months.
From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07524777