Completed

Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma

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What is being tested

BIFICO

Drug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 80 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2021
See protocol details

Summary

Principal SponsorTongji Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2021

Actual date on which the first participant was enrolled.

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the digestive system, with a high incidence in the world and the third highest mortality rate among all malignant tumors in China. In recent years, studies have found that intestinal microflora disorder can also promote the occurrence and development of HCC through various ways, such as endotoxemia, metabolic disorders, and increased risk of exposure to HBV and aflatoxin. In the treatment of HCC, in addition to the traditional comprehensive treatment based on surgical resection, the treatment for intestinal microflora disorder also plays a unique role in improving prognosis and alleviating complications. At present, increasing the number of beneficial bacteria through probiotics is an important method to restore the ecological balance of intestinal microorganisms. Probiotics can maintain the balance of intestinal microecology and the integrity of intestinal mucosal barrier by inhibiting the growth of harmful bacteria, stimulating fermentation, stimulating the proliferation of intestinal mucosal cells and activating the immune system. The preliminary study of this project has shown that the difference of intestinal flora in patients with HCC has a certain impact on the recovery speed of liver function after hepatectomy, and the core flora affecting postoperative liver function is bifidobacteria. Meanwhile, animal experiments have also verified that bifidobacteria can improve the postoperative liver function of mice. Therefore, improving the structure and environment of intestinal microorganisms, increasing the colonization of beneficial bacteria and enhancing the diversity of bacteria are very important to accelerate the recovery of liver function after hepatectomy for patients with HCC. In this project, it is planned to use bifidobacteria-rich BIFICO as an intervention drug to sustained medication in the perioperative period of hepatectomy patients with HCC, and observe the recovery of postoperative liver function.

Official TitleClinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
NCT05178524
Principal SponsorTongji Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

5 inclusion criteria required to participate
Age between 18 to 80 years old

Imaging diagnosis of primary HCC, without other malignancies

No antibiotic treatment within two weeks before surgery

Regular diet and no severe diarrhea

Show More Criteria

3 exclusion criteria prevent from participating
No liver resection is performed

No preoperative or postoperative stool samples during the perioperative period

Pathological diagnosis is not HCC

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Continued administration during perioperative period

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The hepatic surgery of Tongji hospital

Wuhan, ChinaOpen The hepatic surgery of Tongji hospital in Google Maps
CompletedOne Study Center