- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683708
Effectiveness Of Symbiotic Therapy In Jaundiced Patients
Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- jaundiced patients scheduled for elective extrahepatic bile duct resections
- age between 18 and 80 year-old Exclusion Criteria:
Exclusion Criteria
- cirrhosis
- American Society of Anesthesiologists (ASA) score 4
- intestinal malabsorption
- emergency surgery
- intolerance to symbiotic
- diagnosis of primary or secondary immunodeficiency
- unresectability
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Symbiotic group
Jaundiced patients who have symbiotic therapy
|
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).
Other Names:
|
No Symbiotic therapy
Jaundiced patients who not have symbiotic therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infectious Morbidity Rate
Time Frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
|
Participants will followed for the duration of hospital stay, an expected average of 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IMMUNE PROFILE
Time Frame: The day before and on postoperative day 7
|
The day before and on postoperative day 7
|
|
RATE OF TRANSLOCATION
Time Frame: Intraoperative
|
a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture
|
Intraoperative
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lorenzo Capussotti, MD, Mauriziano Hospital, Department of General and Oncological surgery
Publications and helpful links
General 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.
- Kanazawa 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.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Symbiotic2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Jaundice
-
POLYSAN Scientific & Technological Pharmaceutical...Completed
-
Shree Birendra HospitalBP Koirala Institute of Health SciencesCompletedObstuctive Jaundice | Radiological Correlation of Obstructive JaundiceNepal
-
Sohag UniversityRecruitingCalcular Obstructive JaundiceEgypt
-
Jiaolin Ning,MDUnknown
-
zhaoyu liuUnknown
-
Turkish Ministry of Health Izmir Teaching HospitalCompleted
-
Sohag UniversityRecruiting
-
University Clinical Centre of KosovaUniversity of ZagrebUnknownObstructive JaundiceSerbia
-
Huazhong University of Science and TechnologyCompletedSurgical Procedure, Unspecified | Obstructive JaundiceChina
-
Sohag UniversityNot yet recruiting
Clinical Trials on Symbiotic therapy
-
Mashhad University of Medical SciencesUnknown
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...University of Bari Aldo MoroCompletedHealthy | Chronic Kidney DiseasesItaly
-
Conselho Nacional de Desenvolvimento Científico...CompletedSigns and Symptoms, Digestive | Dyslipidemia | HIV | Dietary ModificationBrazil
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...University of Bari Aldo MoroCompleted
-
Federal University of Minas GeraisCompletedHead and Neck Cancer | Nutrition Therapy | SynbioticsBrazil
-
Peking Union Medical College HospitalNot yet recruiting
-
Zeynep Kamil Maternity and Pediatric Research and...Completed
-
Hospital de Clinicas de Porto AlegreUnknownColorectal Cancer | Surgical Site InfectionBrazil
-
National University Hospital, SingaporeNational University of SingaporeNot yet recruitingCardiovascular Diseases | Metabolic Syndrome | Non-Alcoholic Fatty Liver Disease
-
Fondazione Don Carlo Gnocchi OnlusUnknownMalnutrition | Pressure UlcerItaly