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NCT07524777Completed

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 · Last updated 28 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
300 (actual)
First submitted
1 Apr 2026
Start date
11 Apr 2026
Primary completion date
31 Jul 2026
Lead sponsor
Ling Zhiqiang
NCT number
NCT07524777

What you commit to

  • Study type: Interventional
  • Participants enrolled: 300
  • From 11 Apr 2026 to the primary completion date, 31 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant medication treatment.

Other illness

  • Suffering from other gastrointestinal system diseases.
  • Organic brain diseases, brain trauma.
  • History of psychiatric disorders, use of psychoactive substances (e.g., drugs).

Other

  • Acute intestinal obstruction.
  • Severe liver or kidney dysfunction.
  • Pregnancy or lactation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.