Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
干预措施: Sporoderm-removed Ganoderma lucidum spore powder (RGLS) (Dietary Supplement)
placebo group
干预措施: Placebo (Other)
结局指标
主要结局
Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention
时间窗: 3 months
次要结局
- Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention.(3 months)
- Changes in gut microbial species from baseline to 3 months of RGLS intervention.(3 months)
- Change in serum metabolites from baseline to 3 months of RGLS intervention.(3 months)
研究者
Ling Zhiqiang
Prof., M.D., PhD,
Zhejiang Cancer Hospital