CBM588 in the Perioperative Period of Radical Gastrectomy for Gastric Cancer: A Single-Center Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: 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 the day of surgery), at a dosage of 40 mg (20 mg per tablet, i.e., 2 tablets) three times daily. The total intervention period is 14 days. During the study, patients in this group are prohibited from using other probiotic preparations or commercial nutritional supplements containing probiotics (such as yogurt, etc.) to ensure the singularity and comparability of the intervention.;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 will be instructed to avoid consuming commercial nutritional supplements containing probiotics (such as yogurt, etc.). This group will complete the clinical observations and data collection concurrently with the probiotic group from 7 days before surgery to 7 days after surgery.; CONDITION: Gastric cancer PRIMARY OUTCOME: Time to first postoperative flatus (hours); SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: e1bf84a4bd68af4994c8f66902848206457da72e
First added on: May 09, 2026