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Probiotics In Colorectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT00936572
First received: July 7, 2009
Last updated: July 9, 2009
Last verified: July 2009
History of Changes
  Purpose

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

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:

U.S. FDA Resources

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
Maltodoxtrin
 Biological: placebo
Maltodoxtrin

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936572

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

No publications provided

ClinicalTrials.gov 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:
Probiotics
La1
BB536
Colorectal surgery
 Intestinal immunity
Dendritic cells
Lymphocyte
Microbiota

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 21, 2013