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PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)
Sponsor: Casa di Cura Dott. Pederzoli
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.
Official title: Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2026-03-15
Completion Date
2030-11-30
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Ospedale Pederzoli
Peschiera del Garda, Verona, Italy