Lactobacillus Plantarum 299v in Colon Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

June 9, 2008

Last Updated Date

June 10, 2008

Start Date ^ICMJE

January 2001

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in intestinal bacterial microflora [ Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00695461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Bacterial translocation [ Time Frame: During surgery ] [ Designated as safety issue: No ]
Inflammatory response (cytokines) [ Time Frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive ] [ Designated as safety issue: No ]
Cell proliferation [ Time Frame: During surgery ] [ Designated as safety issue: No ]
Postoperative complications [ Time Frame: One week after surgery ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Lactobacillus Plantarum 299v in Colon Surgery

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bacterial Translocation
Inflammation
Cell Proliferation

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00695461

Responsible Party

Peter Mangell, MD, Dept of Surgery, Malmö University Hospital

Study ID Numbers ^ICMJE

PRO NAT 004

Study Sponsor ^ICMJE

Malmö University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Peter Mangell, MD

Dept of Surgery, Malmö University Hospital, Malmö, Sweden

Information Provided By

Malmö University Hospital

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP