Status:
COMPLETED
Probiotics In Colorectal Cancer Patients
Lead Sponsor:
University of Milano Bicocca
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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/...
Detailed Description
BACKGROUND AND RATIONALE The administration of probiotic bacteria has been hypothesized to affect the composition of the intestinal microflora with reduction of pathogens in favour of non-pathogens. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00936572
Start Date
October 1 2006
End Date
October 1 2007
Last Update
July 10 2009
Active Locations (1)
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1
Gianotti Luca Vittorio
Monza, Italy, 20052