Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:25 AM
Study NCT ID:
NCT07422103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistical Analysts'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative diarrhea - mean daily stool frequency', 'timeFrame': 'Baseline (preoperative), 1-month post-discharge, 3 months post-discharge', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Stool consistency - Bristol Stool Form Scale (BSFS)', 'timeFrame': 'Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge', 'description': '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.'}, {'measure': 'Health-related quality of life. European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)', 'timeFrame': 'Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.', 'description': '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.'}, {'measure': '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)', 'timeFrame': 'Baseline (preoperative), 1-month post-discharge, and 3 months post-discharge.', 'description': '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.'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': '12 months and 24 months post-discharge', 'description': '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.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '12 months and 24 months post-discharge', 'description': 'Time from surgery to death from any cause (Unit of Measure: months). Assessed during follow-up through clinical records and telephone interviews.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Pancreatic Diseases', 'Gastrointestinal Symptoms', 'Clostridium Butyricum Miyairi'], 'conditions': ['Pancreatic Cancer', 'Pancreatic Diseases', 'Gastrointestinal Symptoms', 'Clostridium Butyricum Miyairi', 'Pancreatoduodenectomy', 'CBM588']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nClostridium 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.\n\nIn 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.\n\nA 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.\n\nPatients 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Patients undergoing pancreaticoduodenectomy\n* Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy\n* Patients with benign or malignant periampullary neoplasms\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Previous or current use of Clostridium butyricum CBM588\n* Lactose intolerance\n* Neoadjuvant chemotherapy or radiotherapy'}, 'identificationModule': {'nctId': 'NCT07422103', 'acronym': 'PAN-CLO-BU', 'briefTitle': 'PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)', 'organization': {'class': 'OTHER', 'fullName': 'Casa di Cura Dott. Pederzoli'}, 'officialTitle': 'Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study', 'orgStudyIdInfo': {'id': '760CET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clostridium butyricum CBM588', 'description': 'Participants randomized to the experimental arm will receive Clostridium butyricum CBM588 (Butirrisan®) supplementation in addition to standard postoperative care following pancreaticoduodenectomy.', 'interventionNames': ['Other: Clostridium butyricum CBM588 Strain']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Clostridium butyricum CBM588 Strain', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Clostridium butyricum CBM588']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37019', 'city': 'Peschiera del Garda', 'state': 'Verona', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Butturini, MD, PhD', 'role': 'CONTACT', 'email': 'giovanni.butturini@ospedalepederzoli.it', 'phone': '+390456449283'}], 'facility': 'Ospedale Pederzoli', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}], 'centralContacts': [{'name': 'Erica Pizzocaro, MSC', 'role': 'CONTACT', 'email': 'erica.pizzocaro@ospedalepederzoli.it', 'phone': '+390456449283'}, {'name': 'Alice Cattelani, MD', 'role': 'CONTACT', 'email': 'alice.cattelani@outlook.it'}], 'overallOfficials': [{'name': 'Giovanni Butturini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Pederzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa di Cura Dott. Pederzoli', 'class': 'OTHER'}, 'collaborators': [{'name': 'PharmExtracta S.p.A.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}