Inflammation Clinical Trial
— Lp 299vOfficial title:
L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Surgery, Malmö University Hospital | Malmö |
Lead Sponsor | Collaborator |
---|---|
Skane University Hospital |
Sweden,
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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