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Completed

NCT Number: NCT00695461

Lactobacillus Plantarum 299v in Colon Surgery

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.

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Key information

Conditions

Bacterial Translocation Cell Proliferation Hyperplasia Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Surgery, Malmö University Hospital

Malmö, S-20502, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus plantarum 299v in oatmeal drink

Dietary Supplement

Bacteria in a concentration of 10(9) CFU/ml

Oatmeal drink

Dietary Supplement

Oatmeal drink as in arm 1 but without bacteria added.

Primary outcomes

  1. Change in intestinal bacterial microflora

    Time frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months

Secondary outcomes

  1. Bacterial translocation

    Time frame: During surgery

  2. Inflammatory response (cytokines)

    Time frame: Preoperative, during operation, 3, 24 an 48 hours postoperastive

  3. Cell proliferation

    Time frame: During surgery

  4. Postoperative complications

    Time frame: One week after surgery

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Registry information

Official study title

L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study

Acronym: Lp 299v

Important dates

Study start
2001
Primary completion
2004
Study completion
2006
First posted
Jun 11, 2008
Registry last updated
Jun 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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