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NCT07422103Not yet recruiting

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

Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
158 (estimated)
First submitted
3 Feb 2026
Start date
15 Mar 2026
Primary completion date
30 Nov 2028
Lead sponsor
Casa di Cura Dott. Pederzoli
NCT number
NCT07422103

What you commit to

  • Study type: Interventional
  • Planned participants: 158
  • From 15 Mar 2026 to the primary completion date, 30 Nov 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or current use of Clostridium butyricum CBM588
  • Neoadjuvant chemotherapy or radiotherapy

Age

  • Age \< 18 years

Other

  • Lactose intolerance

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedale Pederzoli
Coordinator of this site? Confirm its status
Peschiera del GardaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.