Lactobacillus Plantarum 299v in Colon Surgery (Lp 299v)

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00695461
First received: June 9, 2008
Last updated: June 10, 2008
Last verified: June 2008
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014