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

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.

Interventions

• Clostridium butyricum CBM588 Strain · OTHER

  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 · OTHER

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Age ≥ 18 years
* Written informed consent
* Patients undergoing pancreaticoduodenectomy
* Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy
* Patients with benign or malignant periampullary neoplasms

Exclusion Criteria:

* Age \< 18 years
* Previous or current use of Clostridium butyricum CBM588
* Lactose intolerance
* Neoadjuvant chemotherapy or radiotherapy

Sites (1)

• Ospedale Pederzoli, Peschiera del Garda, Verona, Italy