Lactobacillus Plantarum 299v in Colon Surgery

Study Overview
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Brief Summary
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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.

Official Title
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L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study

Conditions
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Bacterial Translocation, Inflammation, Cell Proliferation

Intervention / Treatment
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* Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink
* Dietary Supplement: Oatmeal drink


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Bacteria in a concentration of 10(9) CFU/ml<br>|
| Placebo Comparator: 2<br>Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery. | Dietary Supplement: Oatmeal drink<br>* Oatmeal drink as in arm 1 but without bacteria added.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intestinal bacterial microflora |  | Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial translocation |  | During surgery | 
| Inflammatory response (cytokines) |  | Preoperative, during operation, 3, 24 an 48 hours postoperastive | 
| Cell proliferation |  | During surgery | 
| Postoperative complications |  | One week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Probiotics, Lactobacillus, Bacterial translocation, Postoperative complications, Inflammatory reaction