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

Skane University Hospital

Status: Completed

Conditions: Cell Proliferation; Bacterial Translocation; Inflammation

Treatments: Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink; Dietary Supplement: Oatmeal drink

Study type: Interventional

Funder types: Other

Identifiers

NCT00695461

PRO NAT 004

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink

2

Placebo Comparator group

Description:

Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.

Treatment:

Dietary Supplement: Oatmeal drink