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

NCT07422103 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-02-19

No results posted yet for this 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.

Conditions

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • PharmExtracta S.p.A.

    collaborator UNKNOWN

  • Casa di Cura Dott. Pederzoli

    lead OTHER

Principal Investigators

  • Giovanni Butturini, MD, PhD · Ospedale Pederzoli

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2028-11-30
Completion
2030-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07422103 on ClinicalTrials.gov