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

June 10, 2008 updated by: Skane University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, S-20502
        • Dept of Surgery, Malmö University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Lactobacillus plantarum 299v in oatmeal drink
Bacteria in a concentration of 10(9) CFU/ml
Placebo Comparator: 2
Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
Dietary supplement: Oatmeal drink
Oatmeal drink as in arm 1 but without bacteria added.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in intestinal bacterial microflora
Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months
Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacterial translocation
Time Frame: During surgery
During surgery
Inflammatory response (cytokines)
Time Frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive
Preoperative, during operation, 3, 24 an 48 hours postoperastive
Cell proliferation
Time Frame: During surgery
During surgery
Postoperative complications
Time Frame: One week after surgery
One week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skane University Hospital

Investigators

  • Principal Investigator: Peter Mangell, MD, Dept of Surgery, Malmö University Hospital, Malmö, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 11, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2008

Last Update Submitted That Met QC Criteria

June 10, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO NAT 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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