Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07263217
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Spirulina — DIETARY_SUPPLEMENT
    participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery
  • Maltodextrin — DIETARY_SUPPLEMENT
    Participants take placebo tablets (maltodextrin, same dosage and schedule).

Study Details

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.

Key Dates

First listed
Dec 4, 2025
Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: Spirulina treatment group
    participants take spirulina tablets (2 g/day) for 3 weeks before and 3 weeks after surgery.
  • Placebo Comparator: Placebo control group
    participants take placebo tablets (maltodextrin, same dosage and schedule).

Primary Outcome Measure

Change in Alanine Aminotransferase (ALT) Level [ Time Frame: Day 0 (pre-treatment, ~3 weeks before surgery) End of 6-week treatment (~3 weeks after surgery) ]

Central Contacts

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