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.
Age ≥ 18 years
Written informed consent
Patients undergoing pancreaticoduodenectomy
Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy
Age < 18 years
Previous or current use of Clostridium butyricum CBM588
Lactose intolerance
Neoadjuvant chemotherapy or radiotherapy
Parallel
Clostridium butyricum CBM588 Strain
Other interventionButirrisan® 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
Other interventionPlacebo 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.
Postoperative diarrhea - mean daily stool frequency
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.
Stool consistency - Bristol Stool Form Scale (BSFS)
Stool consistency assessed using the Bristol Stool Form Scale, a 7-point ordinal scale ranging from Type 1 to Type 7 (Unit of Measure: score on a scale, 1-7); higher scores indicate looser or watery stools. Data collected through a patient-reported daily stool diary.
Health-related quality of life. European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Health-related quality of life measured with the EORTC QLQ-C30 Global Health Status/QoL scale (Unit of Measure: score on a scale, 0-100); higher scores indicate better quality of life. Collected via follow-up questionnaires.
Pancreatic cancer-specific quality of life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26 (EORTC QLQ-PAN26)
Pancreatic cancer-specific quality of life assessed using the EORTC QLQ-PAN26 questionnaire (Unit of Measure: score on a scale, 0-100); for symptom scales/items, higher scores indicate worse symptoms/problems (per EORTC scoring). Collected via follow-up questionnaires.
Disease-free survival (DFS)
Time from surgery to first documented disease recurrence or death from any cause, whichever occurs first (Unit of Measure: months). Assessed during follow-up through clinical records and telephone interviews.
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Casa di Cura Dott. Pederzoli
Lead sponsor
PharmExtracta S.p.A.
Collaborator
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