search
Back to results

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

Primary Purpose

Bacterial Translocation, Inflammation, Cell Proliferation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lactobacillus plantarum 299v in oatmeal drink
Oatmeal drink
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Translocation focused on measuring Colorectal surgery, Probiotics, Lactobacillus, Bacterial translocation, Postoperative complications, Inflammatory reaction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept of Surgery, Malmö University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in intestinal bacterial microflora

Secondary Outcome Measures

Bacterial translocation
Inflammatory response (cytokines)
Cell proliferation
Postoperative complications

Full Information

First Posted
June 9, 2008
Last Updated
June 10, 2008
Sponsor
Skane University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00695461
Brief Title
Lactobacillus Plantarum 299v in Colon Surgery
Acronym
Lp 299v
Official Title
L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Skane University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Translocation, Inflammation, Cell Proliferation
Keywords
Colorectal surgery, Probiotics, Lactobacillus, Bacterial translocation, Postoperative complications, Inflammatory reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum 299v in oatmeal drink
Intervention Description
Bacteria in a concentration of 10(9) CFU/ml
Intervention Type
Dietary Supplement
Intervention Name(s)
Oatmeal drink
Intervention Description
Oatmeal drink as in arm 1 but without bacteria added.
Primary Outcome Measure Information:
Title
Change in intestinal bacterial microflora
Time Frame
Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months
Secondary Outcome Measure Information:
Title
Bacterial translocation
Time Frame
During surgery
Title
Inflammatory response (cytokines)
Time Frame
Preoperative, during operation, 3, 24 an 48 hours postoperastive
Title
Cell proliferation
Time Frame
During surgery
Title
Postoperative complications
Time Frame
One week after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mangell, MD
Organizational Affiliation
Dept of Surgery, Malmö University Hospital, Malmö, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Surgery, Malmö University Hospital
City
Malmö
ZIP/Postal Code
S-20502
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Lactobacillus Plantarum 299v in Colon Surgery

We'll reach out to this number within 24 hrs