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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00695461
Other study ID # PRO NAT 004
Secondary ID
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


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
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