Lactobacillus Plantarum 299v in Colon Surgery (Lp 299v)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00695461|
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Translocation Inflammation Cell Proliferation||Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink Dietary Supplement: Oatmeal drink||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||August 2006|
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.
- Change in intestinal bacterial microflora [ Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months ]
- Bacterial translocation [ Time Frame: During surgery ]
- Inflammatory response (cytokines) [ Time Frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive ]
- Cell proliferation [ Time Frame: During surgery ]
- Postoperative complications [ Time Frame: One week after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695461
|Dept of Surgery, Malmö University Hospital|
|Malmö, Sweden, S-20502|
|Principal Investigator:||Peter Mangell, MD||Dept of Surgery, Malmö University Hospital, Malmö, Sweden|