Bacterial TranslocationLp 299vNCT00695461
Lactobacillus Plantarum 299v in Colon Surgery
A study testing Lactobacillus plantarum 299v in oatmeal drink and Oatmeal drink in people with Bacterial Translocation and Inflammation, run by Skane University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Translocation, Inflammation, Cell Proliferation
- What is being tested?
- Lactobacillus plantarum 299v in oatmeal drink and Oatmeal drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2001to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- planned resection of colon for malignant or benign disease
- all ages
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
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.
- Conditions
- Bacterial Translocation, Inflammation, Cell Proliferation
- Being tested
- Lactobacillus plantarum 299v in oatmeal drink, Oatmeal drink
- Keywords
- Colorectal surgery, Probiotics, Lactobacillus, Bacterial translocation, Postoperative complications, Inflammatory reaction
- Medical subject headings
- Inflammation, Hyperplasia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum 299v in oatmeal drinkDietary supplement
Bacteria in a concentration of 10(9) CFU/ml
Oatmeal drinkDietary supplement
Oatmeal drink as in arm 1 but without bacteria added.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Oatmeal drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intestinal bacterial microflora
Measured: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months
Secondary outcomes (4)
Bacterial translocation
Measured: During surgery
Inflammatory response (cytokines)
Measured: Preoperative, during operation, 3, 24 an 48 hours postoperastive
Cell proliferation
Measured: During surgery
Postoperative complications
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJan 2001
- Primary completionJun 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial TranslocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peter Mangell, MD, Principal investigator, Dept of Surgery, Malmö University Hospital, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695461
- Sponsor's protocol ID
- PRO NAT 004
- Acronym
- Lp 299v
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L Plantarum 299v to Patients Undergoing Colon Resection - a Randomized Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00695461
- Acronym / sponsor ID
- Lp 299v / PRO NAT 004
- Conditions
- Bacterial Translocation, Inflammation, Cell Proliferation
- Keywords
- Colorectal surgery, Probiotics, Lactobacillus, Bacterial translocation, Postoperative complications, Inflammatory reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Lactobacillus plantarum 299v in oatmeal drinkReceives 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. |
| 2 | Placebo comparator | Dietary Supplement: Oatmeal drinkReceives oatmeal drink, 100 ml per day, starting one week before surgery, finishing 5 days after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- planned resection of colon for malignant or benign disease
- all ages
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarum 299v in oatmeal drinkBacteria in a concentration of 10(9) CFU/ml | Dietary supplement | 1 |
| Oatmeal drinkOatmeal drink as in arm 1 but without bacteria added. | Dietary supplement | 2 |
Primary outcome
Change in intestinal bacterial microflora
Time frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Mangell, MD principal investigator
Dept of Surgery, Malmö University Hospital, Malmö, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum 299v in oatmeal drink and Oatmeal drink in people with Bacterial Translocation and Inflammation, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intestinal bacterial microflora (time frame: Before inclusion, after treatment, during surgery, postoperative day 6, 6 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2008.