Lactobacillus Plantarum 299v in Colon Surgery (Lp 299v)

• ClinicalTrials.gov Identifier: NCT00695461
• Recruitment Status: Completed
• First Posted: June 11, 2008
• Last Update Posted: June 11, 2008
• Sponsor: Skane University Hospital
• Information provided by: Skane University Hospital

Tracking Information

• First Submitted Date: June 9, 2008
• First Posted Date: June 11, 2008
• Last Update Posted Date: June 11, 2008
• Study Start Date: January 2001
• Actual Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 10, 2008): Change in intestinal bacterial microflora [ Time Frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 10, 2008)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Lactobacillus Plantarum 299v in Colon Surgery
• Official Title: L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Bacterial Translocation
• Inflammation
• Cell Proliferation

Intervention

• Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink
  Bacteria in a concentration of 10(9) CFU/ml
• Dietary Supplement: Oatmeal drink
  Oatmeal drink as in arm 1 but without bacteria added.

Study Arms

• 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.
  Intervention: Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drink
• Placebo Comparator: 2
  Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.
  Intervention: Dietary Supplement: Oatmeal drink

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2008): 72
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2006
• Actual Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00695461
• Other Study ID Numbers: PRO NAT 004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Peter Mangell, MD, Dept of Surgery, Malmö University Hospital
• Study Sponsor: Skane University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter Mangell, MD; Dept of Surgery, Malmö University Hospital, Malmö, Sweden

• PRS Account: Skane University Hospital
• Verification Date: June 2008