Ganoderma Spores Modulate the Gut-Brain Axis

Sponsor
Ling Zhiqiang
Study ID
NCT07524777
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Apr 11, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
  • Placebo Comparator: placebo group

Primary Outcome Measure

Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention [ Time Frame: 3 months ]

Central Contacts

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