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

NCT05178524 | Completed

• 1 other identifier: TJ-IRB20210532
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Gut Microbiota; Hepatocellular Carcinoma; Bifidobacterium

Outcome Measures

Primary Outcomes (5)

• Comparison of liver function recovery with total bilirubin and prothrombin activity

  The liver function recovery of the two groups on the fifth day after surgery was compared, and t-test was used to verify whether there was a significant difference between the two groups. Total bilirubin and prothrombin activity were used to assess liver function.

  Five days after the surgery

• The alpha and beta diversity analysis of gut microbiota

  We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between two groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.

  Baseline (Before the surgery)

• The alpha and beta diversity analysis of gut microbiota

  We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between two groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.

  Five days after the surgery

• Species composition and differential analysis of gut microbiota

  We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample; the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between the two groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.

  Baseline (Before the surgery)

• Species composition and differential analysis of gut microbiota

  We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample; the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between the two groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.

  Five days after the surgery

Study Arms (2)

Bifico Group

EXPERIMENTAL

Continued administration during perioperative period

Drug: BIFICO

Control Group

NO INTERVENTION

No intervention

Interventions

BIFICO DRUG

Live combined Bifidobacterium, Lactobacillus and Enterococcus Capsules

Bifico Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Laparoscopic or open hepatectomy is performed

You may not qualify if:

• No liver resection is performed
• No preoperative or postoperative stool samples during the perioperative period
• Pathological diagnosis is not HCC

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

The hepatic surgery of Tongji hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Yu J, Zhu P, Shi L, Gao N, Li Y, Shu C, Xu Y, Yu Y, He J, Guo D, Zhang X, Wang X, Shao S, Dong W, Wang Y, Zhang W, Zhang W, Chen WH, Chen X, Liu Z, Yang X, Zhang B. Bifidobacterium longum promotes postoperative liver function recovery in patients with hepatocellular carcinoma. Cell Host Microbe. 2024 Jan 10;32(1):131-144.e6. doi: 10.1016/j.chom.2023.11.011. Epub 2023 Dec 12.

  PMID: 38091982 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bixiang Zhang

  Tongji Hospital

  STUDY CHAIR

• Jingjing Yu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of General Surgery

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: January 5, 2022
• Study Start: June 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-05

Locations

CN (1)