Lactobacillus Plantarum 299v in Colon Surgery

Not Applicable

Completed

• Conditions: Bacterial Translocation; Inflammation; Cell Proliferation
• Interventions: Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink; Dietary Supplement: Oatmeal drink

• Registration Number: NCT00695461
• Lead Sponsor: Skane University Hospital

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 available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2004-06
• Study Completion: 2006-08
• Status Verified: 2008-06
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Last Update Submitted: 2008-06-10
• Study First Posted: 2008-06-11
• Last Update Posted: 2008-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lactobacillus plantarum 299v in oatmeal drink	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.
2	Oatmeal drink	Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.

Primary Outcome Measures

Name	Time	Method
Change in intestinal bacterial microflora	Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept of Surgery, Malmö University Hospital; 🇸🇪 Malmö, Sweden