Lactobacillus Plantarum 299v in Colon Surgery - Full Text View

Sponsor:	Skane University Hospital
Information provided by:	Skane University Hospital
ClinicalTrials.gov Identifier:	NCT00695461

Purpose

Intestinal pathogenes are often involved in postoperative complications after colon surgery. Probiotic bacteria, i e live bacteria which have beneficial effects on the host when ingested, have been shown to reduce bacterial translocation in animal studies. However, in humans studies results have varied. The purpose with this study was to find whether high doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the gut, bacterial translocation and cell proliferation in patients undergoing planned colon surgery.

Condition	Intervention
Bacterial Translocation Inflammation Cell Proliferation	Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink Dietary Supplement: Oatmeal drink

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study

Further study details as provided by Skane University Hospital:

Primary Outcome Measures:

Change in intestinal bacterial microflora [ Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacterial translocation [ Time Frame: During surgery ] [ Designated as safety issue: No ]
Inflammatory response (cytokines) [ Time Frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive ] [ Designated as safety issue: No ]
Cell proliferation [ Time Frame: During surgery ] [ Designated as safety issue: No ]
Postoperative complications [ Time Frame: One week after surgery ] [ Designated as safety issue: Yes ]

Enrollment:	72
Study Start Date:	January 2001
Study Completion Date:	August 2006
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Receives Lactobacillus plantarum 299v in an oatmeal drink, at a concentration of 10(9) colony-forming-units/ml, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.	Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink Bacteria in a concentration of 10(9) CFU/ml
Placebo Comparator: 2 Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.	Dietary Supplement: Oatmeal drink Oatmeal drink as in arm 1 but without bacteria added.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

planned resection of colon for malignant or benign disease
all ages

Exclusion Criteria:

unable to understand instructions and perform preoperative intake of study preparation
rectal surgery
present or past history of endocarditis
congenital or acquired valvular heart disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695461

Locations

Sweden
Dept of Surgery, Malmö University Hospital
Malmö, Sweden, S-20502

Sponsors and Collaborators

Skane University Hospital

Investigators

Principal Investigator:

Peter Mangell, MD

Dept of Surgery, Malmö University Hospital, Malmö, Sweden

More Information

No publications provided

Responsible Party:	Peter Mangell, MD, Dept of Surgery, Malmö University Hospital
ClinicalTrials.gov Identifier:	NCT00695461 History of Changes
Other Study ID Numbers:	PRO NAT 004
Study First Received:	June 9, 2008
Last Updated:	June 10, 2008
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Skane University Hospital:

Colorectal surgery
Probiotics
Lactobacillus

Bacterial translocation
Postoperative complications
Inflammatory reaction

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012