Lactobacillus Plantarum 299v in Colon Surgery (Lp 299v)
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ClinicalTrials.gov Identifier: NCT00695461 |
Recruitment Status :
Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |

Arm | Intervention/treatment |
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Experimental: 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.
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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.
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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 ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Sweden | |
Dept of Surgery, Malmö University Hospital | |
Malmö, Sweden, S-20502 |
Principal Investigator: | Peter Mangell, MD | Dept of Surgery, Malmö University Hospital, Malmö, Sweden |
Responsible Party: | Peter Mangell, MD, Dept of Surgery, Malmö University Hospital |
ClinicalTrials.gov Identifier: | NCT00695461 |
Other Study ID Numbers: |
PRO NAT 004 |
First Posted: | June 11, 2008 Key Record Dates |
Last Update Posted: | June 11, 2008 |
Last Verified: | June 2008 |
Colorectal surgery Probiotics Lactobacillus |
Bacterial translocation Postoperative complications Inflammatory reaction |
Inflammation Pathologic Processes |