Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT07524777

Ganoderma Spores Modulate the Gut-Brain Axis

Led by Ling Zhiqiang · Updated on 2026-05-12

300

Participants Needed

1

Research Sites

20 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Ganoderma Spores Modulate the Gut-Brain Axis

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

Z

Zhiqiang Ling

CONTACT

J

Jinbiao Shang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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