Ganoderma Spores Modulate the Gut-Brain Axis
Recruiting · NCT07524777 · Interventional (participants receive a specific treatment) · Lead sponsor: Ling Zhiqiang
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSporoderm-removed Ganoderma lucidum spore powder (RGLS)
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China