Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Sporoderm-removed Ganoderma lucidum spore powder (RGLS) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
- interventionNames
- Dietary Supplement: Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention
- timeFrame
- 3 months
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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