Probiotics In Colorectal Cancer Patients

This study has been completed.
Information provided by:
University of Milano Bicocca Identifier:
First received: July 7, 2009
Last updated: July 9, 2009
Last verified: July 2009

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 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

Condition Intervention Phase
Colorectal Cancer
Procedure: Probiotics (La1, BB536)
Biological: probiotics (La1, BB536)
Biological: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Trial of Perioperative Administration of Probiotics in Colorectal Cancer Patients.

Resource links provided by NLM:

Further study details as provided by University of Milano Bicocca:

Primary Outcome Measures:
  • Primary Efficacy Parameters: morphological and microbiological evaluation of the colonic microflora, gastrointestinal function [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary Efficacy Parameters: immune and inflammatory response, bacterial translocation

Enrollment: 35
Study Start Date: October 2006
Study Completion Date: October 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high dose
high dose of probiotics (109 cfu)
Procedure: Probiotics (La1, BB536)
Experimental: low dose
low dose of probiotics (107 cfu)
Biological: probiotics (La1, BB536)
Placebo Comparator: probiotics
Biological: placebo

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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


  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00936572

Gianotti Luca Vittorio
Monza, Italy, 20052
Sponsors and Collaborators
University of Milano Bicocca
  More Information

No publications provided Identifier: NCT00936572     History of Changes
Other Study ID Numbers: 02.06.CLI
Study First Received: July 7, 2009
Last Updated: July 9, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milano Bicocca:
Colorectal surgery
Intestinal immunity
Dendritic cells

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 17, 2014