Gastric cancer
Conditions
Interventions
Probiotic group:Patients in the probiotic group will orally receive CBM588 (Miyairi Clostridium butyricum live tablets) from 7 days before surgery to 7 days after surgery (with the dose withheld on th
Control group:Patients in the control group will not receive any probiotic intervention during the perioperative period. They will not be administered CBM588 or any other probiotic preparations and wi
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed gastric adenocarcinoma by preoperative fiberscopy and pathological examination; 2. Scheduled to undergo laparoscopic or open radical gastrectomy; 3. Aged 18 to 80 years, male or female; 4. Laboratory test results meeting the following surgical criteria: neutrophils >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L, total bilirubin <= 1.5 × upper limit of normal (ULN) (ULN = 2 mg/dL), alanine aminotransferase/aspartate aminotransferase (ALT/AST) <= 2 × ULN (ULN = 40 U/L), and coagulation parameters within the normal range; 5. No psychological, familial, sociological or geographical conditions that could potentially interfere with protocol compliance and follow-up schedule; 6. Provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Other histological types of gastric cancer (squamous cell carcinoma, adenosquamous carcinoma, neuroendocrine tumor, clear cell carcinoma, spindle cell carcinoma, undifferentiated carcinoma); 2. Use of similar live microbial preparations within 1 week prior to study enrollment; 3. History of acute or chronic infectious diseases prior to surgery; 4. History of acute abdominal conditions such as intestinal obstruction, strangulated intestinal obstruction, or peritonitis; 5. History of uncontrolled medical conditions within the past 3 months, such as myocardial infarction; 6. History of alcohol or drug abuse; 7. Presence of metastases; 8. Active liver disease, or liver dysfunction with ALT/AST exceeding 2 times the upper limit of normal (ULN), or total bilirubin level exceeding 1.5 times ULN; 9. Renal insufficiency with blood urea nitrogen (BUN) level exceeding 2 times ULN; 10. Surgery postponed or impossible to perform due to unforeseen reasons; 11. Known allergy to the investigational drug; 12. Poor compliance with the study protocol; 13. Presence of uncontrolled severe hypertension or diabetes; 14. Participation in other drug trials within 3 months prior to enrollment; 15. Other specific circumstances deemed unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first postoperative flatus (hours); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first postoperative defecation (hours);Time to first intake of clear liquids (hours);Time to first intake of semi-liquids (hours);Incidence of postoperative complications (abdominal infection, diarrhea, anastomotic leakage, intestinal obstruction, reoperation, etc.);Immune function indicators, including immune cell proportions and cytokine levels; | — |
Countries
China
Contacts
Public ContactChen Huang
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed