Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborators:
Binzhou Medical University Binzhou People's Hospital Dongying People's Hospital Jinan Central Hospital Liaocheng People's Hospital Qianfoshan Hospital Qilu Hospital of Shandong University Qingdao Municipal Hospital Rizhao People's Hospital Shandong Cancer Hospital and Institute Shandong Jining No.1 People's Hospital Shandong Provincial Hospital The People's Hospital of Jimo.Qingdao The Second Hospital of Shandong University Weifang Medical University Weifang People's Hospital Weihai Central Hospital Weihai Municipal Hospital Yantai Yuhuangding Hospital