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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695461
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
Sponsor:
Information provided by:
Skane University Hospital

Tracking Information
First Submitted Date  ICMJE June 9, 2008
First Posted Date  ICMJE June 11, 2008
Last Update Posted Date June 11, 2008
Study Start Date  ICMJE January 2001
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
Change in intestinal bacterial microflora [ Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
  • Bacterial translocation [ Time Frame: During surgery ]
  • Inflammatory response (cytokines) [ Time Frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive ]
  • Cell proliferation [ Time Frame: During surgery ]
  • Postoperative complications [ Time Frame: One week after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactobacillus Plantarum 299v in Colon Surgery
Official Title  ICMJE L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Bacterial Translocation
  • Inflammation
  • Cell Proliferation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2008)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00695461
Other Study ID Numbers  ICMJE PRO NAT 004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Mangell, MD, Dept of Surgery, Malmö University Hospital
Study Sponsor  ICMJE Skane University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Mangell, MD Dept of Surgery, Malmö University Hospital, Malmö, Sweden
PRS Account Skane University Hospital
Verification Date June 2008

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