Postoperative InfectionsNCT01683708
Effectiveness Of Symbiotic Therapy In Jaundiced Patients
An observational study of Postoperative Infections and Jaundice, run by Azienda Ospedaliera Ordine Mauriziano di Torino.
Trial summary
The aim of the present study was therefore to evaluate if the perioperative administration of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for hepato-biliary and pancreatic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Infections, Jaundice
- What is being tested?
- Symbiotic therapy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to not given
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Jaundiced patients scheduled for hepato-biliary pancreatic surgery
Who may be able to join
- jaundiced patients scheduled for elective extrahepatic bile duct resections
- age between 18 and 80 year-old Exclusion Criteria:
Who cannot join
- cirrhosis
- American Society of Anesthesiologists (ASA) score 4
- intestinal malabsorption
- emergency surgery
- intolerance to symbiotic
- diagnosis of primary or secondary immunodeficiency
- unresectability
About this study
Official title: Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
The aim of the present study was therefore to evaluate if the perioperative administration of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for hepato-biliary and pancreatic surgery.
Read the detailed description
Despite advances in preoperative patient's selection and anesthetic and surgical techniques, surgery in jaundiced patients is associated with significant morbidity and mortality as a consequence of septic complications. The evidence that nosocomial infections are frequently a consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of the "gut derived sepsis". Indeed, several studies have reported that jaundiced patients present an increased intestinal permeability and consequently a higher rate of bacterial migration from gastrointestinal tract across the lamina propria to local mesenteric lymph nodes and from there to extra-intestinal site. This phenomenon increases after surgical decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced patients is related to different mechanisms such as mucosal atrophy secondary to protracted absence of intraluminal bile that open para-cellular route for bacterial translocation and the decreased clearance capacity of Kuppfer secondary to cholestasis.
The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can improve the mucosal barrier function reducing the bacterial translocation of organism to mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating mucosal immune and non-immune mechanisms through antagonism/competition with potential pathogens.
- Conditions
- Postoperative Infections, Jaundice
- Being tested
- Symbiotic therapy
- Keywords
- sepsis, jaundice, symbiotic, translocation, abdominal collection, morbidity
- Medical subject headings
- Jaundice, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbiotic therapyDietary supplement
Also called Prebiotic® (Mediabase s.r.l., Prato, Italy)
Patients randomized into the Symbiotic group received Prebiotic® in a dose of one sachet twice a day for at least 1 week preoperatively. Postoperatively the medication was reintroduced as tolerated, and continued until discharge from hospital. One 4,5 gr sachet of Prebiotic® contains at least 1010 living Bifidobacterium bifidum, 1010 living Streptococcus Thermophilus, 1010 living Streptococcus Salivarius, 3 109 Lactobacillus Acidophilus, 1010 living Lactobacillus Casei, 1010 living Lactobacillus bulgaricus and galactooligosaccharides (4,5 gr).
| Study group | Role | What they receive |
|---|---|---|
| Symbiotic group | Jaundiced patients who have symbiotic therapy Receives: Dietary Supplement: Symbiotic therapy | |
| No Symbiotic therapy | Jaundiced patients who not have symbiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious Morbidity Rate
Measured: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes (2)
IMMUNE PROFILE
Measured: The day before and on postoperative day 7
RATE OF TRANSLOCATION
a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative InfectionsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LorenzoCapussotti, Azienda Ospedaliera Ordine Mauriziano di Torino
- Investigators
- Lorenzo Capussotti, MD, Principal investigator, Mauriziano Hospital, Department of General and Oncological surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683708
- Sponsor's protocol ID
- Symbiotic2012
- Status last verified
- Sep 2012
- First submitted
- 7 Sep 2012
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14. doi: 10.1097/01.sla.0000219039.20924.88.
PubMed 17060763Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.
PubMed 15711820
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01683708
- Acronym / sponsor ID
- Symbiotic2012
- Conditions
- Postoperative Infections, Jaundice
- Keywords
- sepsis, jaundice, symbiotic, translocation, abdominal collection, morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di TorinoUniversity, hospital or other
- Study start
- Nov 2008
- First posted
- 12 Sep 2012 (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.
The aim of the present study was therefore to evaluate if the perioperative administration of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for hepato-biliary and pancreatic surgery.
Detailed description
Despite advances in preoperative patient's selection and anesthetic and surgical techniques, surgery in jaundiced patients is associated with significant morbidity and mortality as a consequence of septic complications. The evidence that nosocomial infections are frequently a consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of the "gut derived sepsis". Indeed, several studies have reported that jaundiced patients present an increased intestinal permeability and consequently a higher rate of bacterial migration from gastrointestinal tract across the lamina propria to local mesenteric lymph nodes and from there to extra-intestinal site. This phenomenon increases after surgical decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced patients is related to different mechanisms such as mucosal atrophy secondary to protracted absence of intraluminal bile that open para-cellular route for bacterial translocation and the decreased clearance capacity of Kuppfer secondary to cholestasis.
The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can improve the mucosal barrier function reducing the bacterial translocation of organism to mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating mucosal immune and non-immune mechanisms through antagonism/competition with potential pathogens.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbiotic group | – | Dietary Supplement: Symbiotic therapyJaundiced patients who have symbiotic therapy |
| No Symbiotic therapy | – | –Jaundiced patients who not have symbiotic therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Jaundiced patients scheduled for hepato-biliary pancreatic surgery
Key inclusion criteria (2 listed)
- jaundiced patients scheduled for elective extrahepatic bile duct resections
- age between 18 and 80 year-old Exclusion Criteria:
Key exclusion criteria (7 listed)
- cirrhosis
- American Society of Anesthesiologists (ASA) score 4
- intestinal malabsorption
- emergency surgery
- intolerance to symbiotic
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 |
|---|---|---|
| Symbiotic therapyAlso: Prebiotic® (Mediabase s.r.l., Prato, Italy)Patients randomized into the Symbiotic group received Prebiotic® in a dose of one sachet twice a day for at least 1 week preoperatively. Postoperatively the medication was reintroduced as tolerated, and continued until discharge from hospital. One 4,5 gr sachet of Prebiotic® contains at least 1010 living Bifidobacterium bifidum, 1010 living Streptococcus Thermophilus, 1010 living Streptococcus Salivarius, 3 109 Lactobacillus Acidophilus, 1010 living Lactobacillus Casei, 1010 living Lactobacillus bulgaricus and galactooligosaccharides (4,5 gr). | Dietary supplement | Symbiotic group |
Primary outcome
Infectious Morbidity Rate
Time frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
2 secondary outcomes
IMMUNE PROFILE
Time frame: The day before and on postoperative day 7
RATE OF TRANSLOCATION
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
- Results publication: PubMed 17060763Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14. doi: 10.1097/01.sla.0000219039.20924.88.
- Results publication: PubMed 15711820Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.
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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.
Lorenzo Capussotti, MD principal investigator
Mauriziano Hospital, Department of General and Oncological surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Infections and Jaundice, run by Azienda Ospedaliera Ordine Mauriziano di Torino.
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 7 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: status not confirmed, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Infectious Morbidity Rate (time frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683708, which also lists 2 linked publications.
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 12 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.