Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT ID: NCT05901779
Last Updated: 2023-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
318 participants
INTERVENTIONAL
2023-04-01
2024-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Probiotic Group
PG (probiotic group) patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis. The intervention begins from the completion of preoperative chemotherapy to the seventh day after surgery.
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.
Control Group
CG (Control Group) patients receive blank control management.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Qianfoshan Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Yantai Yuhuangding Hospital
OTHER
Jining First People's Hospital
OTHER
Weifang Medical University
OTHER
Weifang People's Hospital
OTHER
Dongying People's Hospital
OTHER
Weihai Municipal Hospital
OTHER
Weihai Central Hospital
OTHER
Rizhao People's Hospital
OTHER
Liaocheng People's Hospital
OTHER
Qingdao Municipal Hospital
OTHER
The Second Hospital of Shandong University
OTHER
The People's Hospital of Jimo.Qingdao
UNKNOWN
Binzhou People's Hospital
OTHER
Binzhou Medical University
OTHER
Jinan Central Hospital
OTHER
Shandong Cancer Hospital and Institute
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Principal Investigators
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Yanbing Zhou, MD
Role: STUDY_DIRECTOR
The Affiliated Hospital of Qingdao University
Locations
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Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu G, Cao S, Liu X, Tian Y, Yu W, Chai J, Li L, Wang X, Chu X, Duan Q, Qu J, Wang H, Zhang H, Wang X, Hui X, Yang D, Zhou S, Ding Y, Wang H, Zhou F, Hu B, Guo P, Jiang L, Zhang G, Pan Q, Zhou X, Zhou Y. Effect of perioperative probiotic supplements on the short-term clinical outcomes of patients undergoing laparoscopic or robotic radical gastrectomy after neoadjuvant chemotherapy: Study protocol for a multicenter randomized controlled trial (GISSG2023 - 01 Study). BMC Cancer. 2025 Apr 25;25(1):776. doi: 10.1186/s12885-025-14115-x.
Other Identifiers
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GISSG2023-01
Identifier Type: -
Identifier Source: org_study_id
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