Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
Condition: Gut Microbiota; Hepatocellular Carcinoma; Bifidobacterium
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

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.
    

Intervention name(s): BIFICO
Intervention type(s): Drug
Intervention description(s): Live combined Bifidobacterium, Lactobacillus and Enterococcus Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment