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Lactobacillus Plantarum 299v in Colon Surgery

NCT ID: NCT00695461

Last Updated: 2008-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-08-31

Brief Summary

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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

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Conditions

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Bacterial Translocation Inflammation Cell Proliferation

Keywords

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Colorectal surgery Probiotics Lactobacillus Bacterial translocation Postoperative complications Inflammatory reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lactobacillus plantarum 299v in oatmeal drink

Intervention Type DIETARY_SUPPLEMENT

Bacteria in a concentration of 10(9) CFU/ml

2

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

Group Type PLACEBO_COMPARATOR

Oatmeal drink

Intervention Type DIETARY_SUPPLEMENT

Oatmeal drink as in arm 1 but without bacteria added.

Interventions

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Lactobacillus plantarum 299v in oatmeal drink

Bacteria in a concentration of 10(9) CFU/ml

Intervention Type DIETARY_SUPPLEMENT

Oatmeal drink

Oatmeal drink as in arm 1 but without bacteria added.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dept of Surgery, Malmö University Hospital

Principal Investigators

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Peter Mangell, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Surgery, Malmö University Hospital, Malmö, Sweden

Locations

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Dept of Surgery, Malmö University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PRO NAT 004

Identifier Type: -

Identifier Source: org_study_id