Clinical trial · Interventional
Probiotics In Colorectal Cancer Patients
A Randomized Double-Blind Trial of Perioperative Administration of Probiotics in Colorectal Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy. Product: Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30 Primary objective: Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure) Secondary objectives: * Influence of the probiotic bacteria on the gut microflora * Modulation of the immune and inflammatory response Additional objectives: * Investigate dose effect on La1 colonization * Investigate the effect of La1 colonization, treatment without La1 colonization, and absence of treatment and La1 colonization on other bacteria and on immunological parameters
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Biological | — | UNRESOLVED |
| Probiotics (La1, BB536) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- high dose
- description
- high dose of probiotics (109 cfu)
- interventionNames
- Procedure: Probiotics (La1, BB536)
- type
- EXPERIMENTAL
- label
- low dose
- description
- low dose of probiotics (107 cfu)
- interventionNames
- Biological: probiotics (La1, BB536)
- type
- PLACEBO_COMPARATOR
- label
- probiotics
- description
- Maltodoxtrin
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females between 18 and 80 years of age * Documented cancer disease of the colorectum as diagnos pre-operatively by positive histology. * Documented bowel disease (IBD, diverticular disease etc) as diagnosed by barium X-Ray or endoscopy. * Elective colorectal surgery * Surgical hospital length of stay anticipated to be at least 8 days * Stool sample available at Day-3 pre-operatively * Receiving full enteral / oral nutrition * Written informed consent (by subject or legal guardian) Exclusion Criteria: * Perioperative unresectable tumours * Perioperative neoplastic ascitis * Emergency colorectal surgery * Clinically relevant pulmonary or cardiovascular failure * Liver failure (known cirrhosis or total bilirubin \>3 mg/dl) * Kidney failure (receiving renal dialysis or serum creatinine \>2 mg/dl) * Patients receiving total parenteral nutrition (TPN) * Immunological disorders * Ongoing or recent infections (within last 10 days) * Pregnant (patient's declaration) * Participation in another clinical trial SUBJECT SELECTION CRITERIA * Population Base: Patients with diagnosis of disease of the colorectum, elective for colorectal surgery Inclusion Criteria: * Both sexes with age greater than 18 years. * Documented disease of the colorectum, candidate to major elective surgery. * Provided written informed consent. Exclusion Criteria * Preoperative: * clinically relevant failure of the pulmonary * cardiovascular, renal or hepatic system * ongoing bleeding * immunological disorder * ongoing or recent infections * emergency surgery * Intraoperative: * unresectable tumors * neoplastic ascitis
References
Publications (0)
Data not yet available