Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

Summary

Background: Surgery can significantly improve the prognosis of patients with gastric cancer. However, some patients are at a later stage at diagnosis and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may lead to more postoperative complications. Probiotics have the potential to reduce postoperative complications and infections, but no large sample, multicentre, randomized clinical trials have been conducted in patients with gastric cancer receiving NACT. The aim of this multicentre randomized controlled trial was to investigate the effect of probiotics on postoperative infections and other short-term outcomes in patients with gastric cancer receiving NACT.

Methods/design: This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The experimental group will receive perioperative probiotic supplement and that of the control group will receive blank control management. An estimated 318 patients will be enrolled. The main endpoint for comparison is postoperative infections between the two groups.The experimental group patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis.

Conditions

• Gastric Cancer
• Neoadjuvant Chemotherapy

Interventions

DRUG

live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules

Probiotics capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. Each capsule contained\>10,000,000 colony-forming units (CFUs). This drug can treat endoxemia caused by imbalance of intestinal flora.

Sponsors & Collaborators

• Qilu Hospital of Shandong University

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Weifang Medical University

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Dongying People's Hospital

  collaborator OTHER

• Weihai Municipal Hospital

  collaborator OTHER

• Weihai Central Hospital

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Qingdao Municipal Hospital

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• The People's Hospital of Jimo.Qingdao

  collaborator UNKNOWN

• Binzhou People's Hospital

  collaborator OTHER

• Binzhou Medical University

  collaborator OTHER

• Jinan Central Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  lead OTHER

Principal Investigators

• Yanbing Zhou, MD · The Affiliated Hospital of Qingdao University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-01

Primary Completion

2024-03-01

Completion

2024-05-01

Countries

• China

Study Locations