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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Translocation Inflammation Cell Proliferation Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink Dietary Supplement: Oatmeal drink Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
Study Start Date : January 2001
Actual Primary Completion Date : June 2004
Actual Study Completion Date : August 2006

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in intestinal bacterial microflora [ Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months ]

Secondary Outcome Measures :
  1. Bacterial translocation [ Time Frame: During surgery ]
  2. Inflammatory response (cytokines) [ Time Frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive ]
  3. Cell proliferation [ Time Frame: During surgery ]
  4. Postoperative complications [ Time Frame: One week after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695461


Locations
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Sweden
Dept of Surgery, Malmö University Hospital
Malmö, Sweden, S-20502
Sponsors and Collaborators
Skane University Hospital
Investigators
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Principal Investigator: Peter Mangell, MD Dept of Surgery, Malmö University Hospital, Malmö, Sweden
More Information
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Responsible Party: Peter Mangell, MD, Dept of Surgery, Malmö University Hospital
ClinicalTrials.gov Identifier: NCT00695461    
Other Study ID Numbers: PRO NAT 004
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: June 2008
Keywords provided by Skane University Hospital:
Colorectal surgery
Probiotics
Lactobacillus
 Bacterial translocation
Postoperative complications
Inflammatory reaction
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes