NCT07422103

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
54mo left

Started Mar 2026

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Nov 2030

First Submitted

Initial submission to the registry

February 3, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

February 3, 2026

Last Update Submit

February 12, 2026

Conditions

Pancreatic CancerPancreatic DiseasesGastrointestinal SymptomsClostridium Butyricum MiyairiPancreatoduodenectomyCBM588

Keywords

Pancreatic CancerPancreatic DiseasesGastrointestinal SymptomsClostridium Butyricum Miyairi

Outcome Measures

Primary Outcomes (1)

  • Postoperative diarrhea - mean daily stool frequency

    Mean number of bowel movements per day (Unit of Measure: bowel movements/day \[count\]), recorded using a patient-reported daily stool diary completed after hospital discharge. The primary comparison is between patients receiving Clostridium butyricum CBM588 and placebo.

    Baseline (preoperative), 1-month post-discharge, 3 months post-discharge

Secondary Outcomes (5)

  • Stool consistency - Bristol Stool Form Scale (BSFS)

    Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge

  • Health-related quality of life. European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.

  • Pancreatic cancer-specific quality of life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26 (EORTC QLQ-PAN26)

    Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.

  • Disease-free survival (DFS)

    12 months and 24 months post-discharge

  • Overall survival (OS)

    12 months and 24 months post-discharge

Study Arms (2)

Clostridium butyricum CBM588

EXPERIMENTAL

Participants randomized to the experimental arm will receive Clostridium butyricum CBM588 (Butirrisan®) supplementation in addition to standard postoperative care following pancreaticoduodenectomy.

Other: Clostridium butyricum CBM588 Strain

Placebo

PLACEBO COMPARATOR

Participants randomized to the placebo arm will receive placebo tablets identical in appearance, packaging, and dosing schedule to the experimental product, in addition to standard postoperative care following pancreaticoduodenectomy.

Other: Placebo

Interventions

Clostridium butyricum CBM588 StrainOTHER

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.

Clostridium butyricum CBM588
PlaceboOTHER

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Pederzoli

Peschiera del Garda, Verona, 37019, Italy

Location

Related Publications (1)

  • 1 World Health Organization International Agency for Research on Cancer (IARC) (2020) World Cancer Report: Cancer Research for Cancer Prevention. Available at: http://publications.iarc.fr/586. (accessed 23 August 2024). 2 Ferlay J, Shin HR, Bray F, et al. (2010) Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. International journal of cancer 127(12). Int J Cancer: 2893-2917. 3 Stewart BW and Wild CP (2015) World Cancer Report 2014. 4 Bray F, Laversanne M, Sung H, et al. (2024) Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians 74(3). CA Cancer J Clin: 229-263. 5 Ying H, Dey P, Yao W, et al. (2016) Genetics and biology of pancreatic ductal adenocarcinoma. Genes & Development 30(4). Cold Spring Harbor Laboratory Press: 355. 6 Khan MA, Azim S, Zubair H, et al. (2017) Molecular Drivers of Pancreatic Cancer Pathogenesis: Looking Inward to Move Forward. International journal of molecular sciences 18(4). Int J Mol Sci. 7 Bailey P, Chang DK, Nones K, et al. (2016) Genomic analyses identify molecular subtypes of pancreatic cancer. Nature 531(7592). Nature: 47-52. 8 de Jesus VHF, Mathias-Machado MC, de Farias JPF, et al. (2023) Targeting KRAS in Pancreatic Ductal Adenocarcinoma: The Long Road to Cure. Cancers 15(20). Cancers (Basel). 9 Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, et al. (2023) Pancreatic cancer: Advances and challenges. Cell 186(8). Cell: 1729-1754. 10 Kleeff J, Korc M, Apte M, et al. (2016) Pancreatic cancer. Nature reviews. Disease primers 2. Nat Rev Dis Primers. 11 Huber M, Brehm CU, Gress TM, et al. (2020) The Immune Microenvironment in Pancreatic Cancer. International journal of molecular sciences 21(19). Int J Mol Sci: 1-33. 12 Yang S, Liu Q and Liao Q (2021) Tumor-Associated Macrophages in Pancreatic Ductal Adenocarcinoma: Origin, Polarization, Function, and Reprogramming. Frontiers in Cell and Developmental Biology 8. Frontiers Me

    BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System Diseases

Study Officials

  • Giovanni Butturini, MD, PhD

    Ospedale Pederzoli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Pizzocaro, MSC

CONTACT

+390456449283erica.pizzocaro@ospedalepederzoli.it

Alice Cattelani, MD

CONTACT

alice.cattelani@outlook.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Statistical Analysts
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 19, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2030

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

IT(1)