Lactobacillus Plantarum 299v in Colon Surgery

Inflammation Clinical Trial

— Lp 299v  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695461
• Other study ID #: PRO NAT 004
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: June 10, 2008
• Start date: January 2001
• Est. completion date: August 2006

Study information

• Verified date: June 2008
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2006
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Translocation
• Cell Proliferation
• Inflammation

Intervention

Dietary Supplement:
• Lactobacillus plantarum 299v in oatmeal drink
Bacteria in a concentration of 10(9) CFU/ml
• Oatmeal drink
Oatmeal drink as in arm 1 but without bacteria added.

Locations

Country	Name	City	State
Sweden	Dept of Surgery, Malmö University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intestinal bacterial microflora		Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months	No
Secondary	Bacterial translocation		During surgery	No
Secondary	Inflammatory response (cytokines)		Preoperative, during operation, 3, 24 an 48 hours postoperastive	No
Secondary	Cell proliferation		During surgery	No
Secondary	Postoperative complications		One week after surgery	Yes