NCT05178524

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

On the basis of previous studies, this study intends to explore the effect of BIFICO on liver function recovery of patients with hepatocellular carcinoma (HCC) after surgery, so as to provide a new method for accelerating liver function recovery of HCC patients during perioperative period. This project is an open, randomized, blank-controlled clinical study. Liver resection patients were randomly divided into two groups, one group received continuous administration of BIFICO during perioperative period, and the dosage was controlled according to the instructions. The other group was a blank control. Stool samples were collected at three time points (before medication, before and after surgery) in two groups. Statistical analysis was performed to compare the differences of postoperative liver function and preoperative and postoperative gut microbiota between the two groups. Through this study, the investigators aimed to verify the beneficial changes of intestinal microflora in HCC patients with BIFICO during perioperative period .

Detailed description

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.

Conditions

• Gut Microbiota
• Hepatocellular Carcinoma
• Bifidobacterium

Interventions

Type	Name	Description
DRUG	BIFICO	Live combined Bifidobacterium, Lactobacillus and Enterococcus Capsules

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-05-30
• Completion: 2022-06-30
• First posted: 2022-01-05
• Last updated: 2022-09-02

Locations

1 site across 1 country: China