Pancreatic CancerPAN-CLO-BUNCT07422103
PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)
A study testing Clostridium butyricum CBM588 Strain in people with Pancreatic Cancer and Pancreatic Diseases, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Diseases, Gastrointestinal Symptoms
- What is being tested?
- Clostridium butyricum CBM588 Strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2026to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Previous or current use of Clostridium butyricum CBM588
- Lactose intolerance
- Neoadjuvant chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alice Cattelani, MD contact
Italy1 site
Ospedale Pederzoli
Peschiera del Garda, Verona, 37019
Giovanni Butturini, MD, PhD, +390456449283, giovanni.butturini@ospedalepederzoli.it
About this study
Official title: Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study
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.
Read the detailed description
Pancreaticoduodenectomy is associated with significant postoperative gastrointestinal complications, particularly chronic diarrhea, which negatively impacts nutritional status, quality of life, and the ability to complete adjuvant oncologic treatments. Increasing evidence suggests that alterations in the gut microbiota and reduced production of short-chain fatty acids, especially butyrate, play a key role in postoperative gastrointestinal dysfunction.
Clostridium butyricum CBM588 is a butyrate-producing probiotic with a well-established safety profile and demonstrated efficacy in the management of gastrointestinal disorders. This study aims to assess whether supplementation with Clostridium butyricum CBM588 can reduce postoperative diarrhea-hypothesized as a 40-60% relative reduction compared with placebo-and improve gastrointestinal symptoms and quality of life in patients undergoing pancreaticoduodenectomy.
In addition to gastrointestinal and quality-of-life outcomes, patients will be followed longitudinally for oncological outcomes, including disease-free survival and overall survival, in order to explore potential associations between postoperative gastrointestinal recovery, nutritional status, and long-term clinical outcomes.
A total of 158 patients will be randomized in a 1:1 ratio to receive either Clostridium butyricum CBM588 or placebo for 3 months following hospital discharge. All participants in both study arms will receive standard postoperative care, including individualized nutritional counseling based on a comprehensive assessment of nutritional status and body composition (including bioimpedance analysis) according to a standardized nutritional scheme, as well as pancreatic enzyme replacement therapy prescribed as pancrelipase 50,000 IU with each main meal and 25,000 IU with each snack, in addition to other medical or pharmacological treatments as clinically indicated.
Patients will be followed for gastrointestinal outcomes and quality of life during the intervention period and for disease-free survival and overall survival during long-term follow-up. All participants will be provided with a patient diary to record date and time of study product administration, number of tablets taken, daily bowel movements, and stool consistency according to the Bristol Stool Form Scale.
The enrollment period is expected to last approximately 30 months. The intervention will be administered for 3 months following hospital discharge. The primary endpoint will be assessed at the end of the treatment period, while secondary oncological endpoints will be evaluated during an additional 24-month follow-up.
- Conditions
- Pancreatic Cancer, Pancreatic Diseases, Gastrointestinal Symptoms, Clostridium Butyricum Miyairi, Pancreatoduodenectomy, CBM588
- Being tested
- Clostridium butyricum CBM588 Strain, Placebo
- Keywords
- Pancreatic Cancer, Pancreatic Diseases, Gastrointestinal Symptoms, Clostridium Butyricum Miyairi
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative), 1-month post-discharge, 3 months post-discharge
Secondary outcomes (5)
Stool consistency - Bristol Stool Form Scale (BSFS)
Stool consistency assessed using the Bristol Stool Form Scale, a 7-point ordinal scale ranging from Type 1 to Type 7 (Unit of Measure: score on a scale, 1-7); higher scores indicate looser or watery stools. Data collected through a patient-reported daily stool diary.
Measured: 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)
Health-related quality of life measured with the EORTC QLQ-C30 Global Health Status/QoL scale (Unit of Measure: score on a scale, 0-100); higher scores indicate better quality of life. Collected via follow-up questionnaires.
Measured: 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)
Pancreatic cancer-specific quality of life assessed using the EORTC QLQ-PAN26 questionnaire (Unit of Measure: score on a scale, 0-100); for symptom scales/items, higher scores indicate worse symptoms/problems (per EORTC scoring). Collected via follow-up questionnaires.
Measured: Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.
Disease-free survival (DFS)
Time from surgery to first documented disease recurrence or death from any cause, whichever occurs first (Unit of Measure: months). Assessed during follow-up through clinical records and telephone interviews.
Measured: 12 months and 24 months post-discharge
Overall survival (OS)
Time from surgery to death from any cause (Unit of Measure: months). Assessed during follow-up through clinical records and telephone interviews.
Measured: 12 months and 24 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Collaborators
- PharmExtracta S.p.A.
- Responsible party
- Sponsor
- Investigators
- Giovanni Butturini, MD, PhD, Principal investigator, Ospedale Pederzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422103
- Sponsor's protocol ID
- 760CET
- Acronym
- PAN-CLO-BU
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT07422103
- Acronym / sponsor ID
- PAN-CLO-BU / 760CET
- Conditions
- Pancreatic Cancer, Pancreatic Diseases, Gastrointestinal Symptoms, Clostridium Butyricum Miyairi, Pancreatoduodenectomy, CBM588
- Keywords
- Pancreatic Cancer, Pancreatic Diseases, Gastrointestinal Symptoms, Clostridium Butyricum Miyairi
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Collaborators
- PharmExtracta S.p.A.
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreaticoduodenectomy is associated with significant postoperative gastrointestinal complications, particularly chronic diarrhea, which negatively impacts nutritional status, quality of life, and the ability to complete adjuvant oncologic treatments. Increasing evidence suggests that alterations in the gut microbiota and reduced production of short-chain fatty acids, especially butyrate, play a key role in postoperative gastrointestinal dysfunction.
Clostridium butyricum CBM588 is a butyrate-producing probiotic with a well-established safety profile and demonstrated efficacy in the management of gastrointestinal disorders. This study aims to assess whether supplementation with Clostridium butyricum CBM588 can reduce postoperative diarrhea-hypothesized as a 40-60% relative reduction compared with placebo-and improve gastrointestinal symptoms and quality of life in patients undergoing pancreaticoduodenectomy.
In addition to gastrointestinal and quality-of-life outcomes, patients will be followed longitudinally for oncological outcomes, including disease-free survival and overall survival, in order to explore potential associations between postoperative gastrointestinal recovery, nutritional status, and long-term clinical outcomes.
A total of 158 patients will be randomized in a 1:1 ratio to receive either Clostridium butyricum CBM588 or placebo for 3 months following hospital discharge. All participants in both study arms will receive standard postoperative care, including individualized nutritional counseling based on a comprehensive assessment of nutritional status and body composition (including bioimpedance analysis) according to a standardized nutritional scheme, as well as pancreatic enzyme replacement therapy prescribed as pancrelipase 50,000 IU with each main meal and 25,000 IU with each snack, in addition to other medical or pharmacological treatments as clinically indicated.
Patients will be followed for gastrointestinal outcomes and quality of life during the intervention period and for disease-free survival and overall survival during long-term follow-up. All participants will be provided with a patient diary to record date and time of study product administration, number of tablets taken, daily bowel movements, and stool consistency according to the Bristol Stool Form Scale.
The enrollment period is expected to last approximately 30 months. The intervention will be administered for 3 months following hospital discharge. The primary endpoint will be assessed at the end of the treatment period, while secondary oncological endpoints will be evaluated during an additional 24-month follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clostridium butyricum CBM588 | Experimental | Other: Clostridium butyricum CBM588 StrainParticipants randomized to the experimental arm will receive Clostridium butyricum CBM588 (Butirrisan®) supplementation in addition to standard postoperative care following pancreaticoduodenectomy. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age < 18 years
- Previous or current use of Clostridium butyricum CBM588
- Lactose intolerance
- Neoadjuvant chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clostridium butyricum CBM588 StrainButirrisan® 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 | Clostridium butyricum CBM588 |
| PlaceboPlacebo 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. | Other | Placebo |
Primary outcome
Postoperative diarrhea - mean daily stool frequency
Time frame: Baseline (preoperative), 1-month post-discharge, 3 months post-discharge
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.
5 secondary outcomes
Stool consistency - Bristol Stool Form Scale (BSFS)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.
Disease-free survival (DFS)
Time frame: 12 months and 24 months post-discharge
Overall survival (OS)
Time frame: 12 months and 24 months post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Background1 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Cattelani, MD contact
Giovanni Butturini, MD, PhD principal investigator
Ospedale Pederzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clostridium butyricum CBM588 Strain in people with Pancreatic Cancer and Pancreatic Diseases, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Pizzocaro, MSC (+390456449283, erica.pizzocaro@ospedalepederzoli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative diarrhea - mean daily stool frequency (time frame: Baseline (preoperative), 1-month post-discharge, 3 months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07422103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.