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

Casa di Cura Dott. Pederzoli

Status: Not yet enrolling

Conditions: CBM588; Pancreatic Diseases; Clostridium Butyricum Miyairi; Gastrointestinal Symptoms; Pancreatoduodenectomy; Pancreatic Cancer

Treatments: Other: Clostridium butyricum CBM588 Strain; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07422103

760CET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Clostridium butyricum CBM588

Experimental group

Description:

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

Treatment:

Other: Clostridium butyricum CBM588 Strain

Placebo

Placebo Comparator group

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.

Treatment:

Other: Placebo