NCT00695461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

Enrollment Period

3.4 years

First QC Date

June 9, 2008

Last Update Submit

June 10, 2008

Conditions

Bacterial TranslocationInflammationCell Proliferation

Keywords

Colorectal surgeryProbioticsLactobacillusBacterial translocationPostoperative complicationsInflammatory reaction

Outcome Measures

Primary Outcomes (1)

  • Change in intestinal bacterial microflora

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

Secondary Outcomes (4)

  • Bacterial translocation

    During surgery

  • Inflammatory response (cytokines)

    Preoperative, during operation, 3, 24 an 48 hours postoperastive

  • Cell proliferation

    During surgery

  • Postoperative complications

    One week after surgery

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

Receives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery.

Dietary Supplement: Oatmeal drink

Interventions

Lactobacillus plantarum 299v in oatmeal drinkDIETARY_SUPPLEMENT

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

1
Oatmeal drinkDIETARY_SUPPLEMENT

Oatmeal drink as in arm 1 but without bacteria added.

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • planned resection of colon for malignant or benign disease
  • all ages

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Surgery, Malmö University Hospital

Malmo, S-20502, Sweden

Location

MeSH Terms

Conditions

InflammationHyperplasiaPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Mangell, MD

    Dept of Surgery, Malmö University Hospital, Malmö, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

January 1, 2001

Primary Completion

June 1, 2004

Study Completion

August 1, 2006

Last Updated

June 11, 2008

Record last verified: 2008-06

Locations

SE(1)