The goal of this clinical trial is to learn if spirulina can help protect the liver and promote recovery after partial hepatectomy (surgery to remove part of the liver). It will also learn about the safety of spirulina in patients undergoing liver surgery. The main questions it aims to answer are: Does spirulina help improve liver function after surgery? Does spirulina promote liver regeneration and reduce inflammation? What side effects, if any, occur when participants take spirulina? Researchers will compare spirulina tablets to a placebo (a look-alike tablet that contains no spirulina) to see if spirulina helps protect the liver and support recovery after surgery. Participants will: Take spirulina or placebo tablets daily for 3 weeks before and 3 weeks after surgery. Provide blood and stool samples before and after treatment. Allow the collection of a small piece of liver tissue (from surgical waste) for analysis. Have regular clinic visits for checkups, blood tests, and safety monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery
Participants take placebo tablets (maltodextrin, same dosage and schedule).
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
RECRUITINGChange in Alanine Aminotransferase (ALT) Level
Serum ALT will be measured at baseline and after the 6-week perioperative intervention. The outcome is the change from baseline compared between spirulina and placebo groups.
Time frame: Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Aspartate Aminotransferase (AST) Level
Serum AST will be measured at baseline and after the intervention. The analysis compares change from baseline between study arms.
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Total Bilirubin (TBIL) Level
Serum TBIL will be measured pre- and post-intervention. The change from baseline will be compared between groups.
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Serum Inflammatory Cytokine Concentrations
Serum inflammatory cytokines (e.g., IL-6, TNF-α) will be quantified using immunoassays before and after intervention. Analysis will compare changes from baseline.
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Change in Gut Microbial Species Abundance Measured by Fecal Metagenomic Sequencing
Fecal metagenomic sequencing will assess gut microbial species abundance and alpha-diversity indices. The outcome is change in microbial composition from baseline to post-treatment.
Time frame: Day 0 (~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery)
Gene Expression Profiles from Liver Tissue Assessed by Single-cell and/or Bulk Transcriptomic Sequencing
Single-cell RNA sequencing and/or bulk RNA sequencing will be performed on liver tissue collected during partial hepatectomy to characterize cellular and molecular pathways related to liver injury and regeneration.
Time frame: During liver surgery (partial hepatectomy)
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