Trial Title:
Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT ID:
NCT05901779
Condition:
Gastric Cancer
Neoadjuvant Chemotherapy
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
live combined Bifidobacteriun, Lactobacillus and Enterococcus capsules
Description:
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.
Arm group label:
Probiotic Group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-80 years old
- male and female
- clinical stage was T3/4N+ evaluated by CT/MR/EUS at new diagnosis (before any
anti-cancer treatment) , complete 2-4 cycles preoperative chemotherapy based on 5-FU
(such as SOX, FLOX, ect.) at 3-6 weeks before surgery
- ASA grade was Ⅰ~Ⅲ
- radical minimal-invasive gastrectomy via laparoscope or DaVinci is judged as
possible
- histologically confirmed gastric adenocarcinoma
- ECOG score is 0~1
- patients who provide a written informed consent before entering study screening
Exclusion Criteria:
- need emergency surgery due to performation and/or obstruction
- receive antibiotics and/or glucocorticoids within 14 days before surgery
- exist bacterial infection and/or autoimmune disease and/or IBD currently
- intolerance or allergic to probiotics
- upper abdominal surgery history
- use probiotics within 7 days before intervention, such as yogurt, ect.
- participate in other clinical trials currently
- severe mental illness
- can not participate in this trial due to severe illness of other organs evaluated by
researchers, such as severe cardiac insufficiency (LVEF<30%, NYHA>Ⅱ, severe
arrhythmia, congestive heart failure, myocardial infarction within 6 months), liver
dysfunction (Child-Pugh C), renal dysfunction (need hemodialysis)
- need simultaneous surgery
- lactation or pregnancy
- refuse to participate in this trial
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Yanbing
Phone:
86532-82911324
Email:
zhouyanbing@qduhospital.cn
Start date:
April 1, 2023
Completion date:
May 1, 2024
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Qianfoshan Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Yantai Yuhuangding Hospital
Agency class:
Other
Collaborator:
Agency:
Jining First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Weifang Medical University
Agency class:
Other
Collaborator:
Agency:
Weifang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Dongying People's Hospital
Agency class:
Other
Collaborator:
Agency:
Weihai Municipal Hospital
Agency class:
Other
Collaborator:
Agency:
Weihai Central Hospital
Agency class:
Other
Collaborator:
Agency:
Rizhao People's Hospital
Agency class:
Other
Collaborator:
Agency:
Liaocheng People's Hospital
Agency class:
Other
Collaborator:
Agency:
Qingdao Municipal Hospital
Agency class:
Other
Collaborator:
Agency:
The Second Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
The People's Hospital of Jimo.Qingdao
Agency class:
Other
Collaborator:
Agency:
Binzhou People's Hospital
Agency class:
Other
Collaborator:
Agency:
Binzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Jinan Central Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901779
