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NCT Number: NCT07524777

Ganoderma Spores Modulate the Gut-Brain Axis

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sporoderm-removed Ganoderma lucidum spore powder (RGLS)

Dietary Supplement

From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months.

Placebo

Other

From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.

Primary outcomes

  1. Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention

    Time frame: 3 months

Secondary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention.

    Time frame: 3 months

  2. Changes in gut microbial species from baseline to 3 months of RGLS intervention.

    Time frame: 3 months

  3. Change in serum metabolites from baseline to 3 months of RGLS intervention.

    Time frame: 3 months

Other outcomes

  1. Incidence of adverse events in both groups, including patient-reported symptoms and laboratory parameters.

    Time frame: 3 months

  2. Improvement rate of thyroid function in both groups, assessed by thyroid function parameters.

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jinbiao Shang

CONTACT

[email protected]

Zhiqiang Ling

CONTACT

[email protected]

+86-571-88122423

Sponsors and collaborators

Lead sponsor

Ling Zhiqiang

Other

Registry information

Official study title

Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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