PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)

Condition(s) studied

Investigational drug(s) / intervention(s)

Clostridium butyricum CBM588 Strain: Butirrisan® contains ≥4.5 × 10⁵ CFU of Clostridium butyricum CBM588 per tablet. Participants will receive 6 tablets per day (3 tablets in the morning and 3 tablets in the evening) starting at hospital discharge and continuing for 3 months.

Placebo: Placebo tablets contain lactose and inert components and will be administered at a dosage of 6 tablets per day (3 tablets in the morning and 3 tablets in the evening) starting at hospital discharge and continuing for 3 months.

Study summary

This is a prospective, randomized, double-blind, single-center clinical trial designed to evaluate the effects of Clostridium butyricum CBM588 supplementation on postoperative diarrhea, gastrointestinal symptoms, and quality of life in patients undergoing pancreaticoduodenectomy for periampullary neoplasms. Oncological outcomes, including disease-free survival and overall survival, will be monitored as secondary endpoints during follow-up.

Eligibility

Primary outcome measure(s)

• Postoperative diarrhea - mean daily stool frequency — Baseline (preoperative), 1-month post-discharge, 3 months post-discharge
  Mean number of bowel movements per day (Unit of Measure: bowel movements/day \[count\]), recorded using a patient-reported daily stool diary completed after hospital discharge. The primary comparison is between patients receiving Clostridium butyricum CBM588 and placebo.

Trial sites (1)

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