Lactobacillus Plantarum 299v in Colon Surgery | NCT00695461

Studies
Lactobacillus Plantarum 299v in Colon Surgery

NCT00695461

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Jun 11, 2008Estimated

Enrollment

72Actual

Phase

Not Applicable

Conditions

Bacterial Translocation
Inflammation
Cell Proliferation

Interventions

Lactobacillus plantarum 299v in oatmeal drink
Oatmeal drink

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Jun 2004Actual

Completion Date

Aug 2006Actual

First Submitted Date

Jun 9, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2008

Last Update Posted Date

Jun 11, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lactobacillus plantarum 299v in oatmeal drink	Dietary Supplement	Bacteria in a concentration of 10(9) CFU/ml	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in intestinal bacterial microflora		Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Bacterial translocation		During surgery
Inflammatory response (cytokines)		Preoperative, during operation, 3, 24 an 48 hours postoperastive
Cell proliferation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Mangell, MD	Dept of Surgery, Malmö University Hospital, Malmö, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Surgery, Malmö University Hospital		Malmö		S-20502	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D006965	Hyperplasia
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided