PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clostridium butyricum CBM588 Strain, Placebo.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Pancreatic Diseases, Gastrointestinal Symptoms, Clostridium Butyricum Miyairi. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supplementation With Clostridium Butyricum CBM588 in Patients Undergoing Pancreaticoduodenectomy for Periampullary Neoplasms: A Prospective Randomized Double-Blind Study
Overview
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.
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.
Primary outcome measures
- Postoperative diarrhea - mean daily stool frequency [Time frame: Baseline (preoperative), 1-month post-discharge, 3 months post-discharge]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Age < 18 years
- Previous or current use of Clostridium butyricum CBM588
- Lactose intolerance
- Neoadjuvant chemotherapy or radiotherapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Ospedale Pederzoli — Peschiera del Garda
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 Stewa
Identifiers
NCT: NCT07422103 · 760CET