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
Casa di Cura Dott. Pederzoli
Lead sponsor
PharmExtracta S.p.A.
Collaborator