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Lactobacillus Plantarum 299v in Colon Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00695461
Acronym
Lp 299v
Enrollment
72
Registered
2008-06-11
Start date
2001-01-31
Completion date
2006-08-31
Last updated
2008-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Translocation, Cell Proliferation, Inflammation

Keywords

Colorectal surgery, Probiotics, Lactobacillus, Bacterial translocation, Postoperative complications, Inflammatory reaction

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus plantarum 299v in oatmeal drink

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

DIETARY_SUPPLEMENTOatmeal drink

Oatmeal drink as in arm 1 but without bacteria added.

Sponsors

Skane University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Change in intestinal bacterial microfloraBefore inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months

Secondary

MeasureTime frame
Bacterial translocationDuring surgery
Inflammatory response (cytokines)Preoperative, during operation, 3, 24 an 48 hours postoperastive
Cell proliferationDuring surgery
Postoperative complicationsOne week after surgery

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026