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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

June 9, 2008
June 10, 2008
January 2001
June 2004   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00695461 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lactobacillus Plantarum 299v in Colon Surgery
L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Bacterial Translocation
  • Inflammation
  • Cell Proliferation
  • Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink
    Bacteria in a concentration of 10(9) CFU/ml
  • Dietary Supplement: Oatmeal drink
    Oatmeal drink as in arm 1 but without bacteria added.
  • 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.
    Intervention: Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink
  • Placebo Comparator: 2
    Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
    Intervention: Dietary Supplement: Oatmeal drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2006
June 2004   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00695461
PRO NAT 004
No
Peter Mangell, MD, Dept of Surgery, Malmö University Hospital
Skane University Hospital
Not Provided
Principal Investigator: Peter Mangell, MD Dept of Surgery, Malmö University Hospital, Malmö, Sweden
Skane University Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP