L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Skane University Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Change in intestinal bacterial microflora
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •planned resection of colon for malignant or benign disease
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
Arms & Interventions
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: Lactobacillus plantarum 299v in oatmeal drink (Dietary Supplement)
2
Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
Intervention: Oatmeal drink (Dietary Supplement)
Outcomes
Primary Outcomes
Change in intestinal bacterial microflora
Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months
Secondary Outcomes
- 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)