Effectiveness Of Symbiotic Therapy In Jaundiced Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial

Conditions
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Postoperative Infections, Jaundice

Intervention / Treatment
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* Dietary Supplement: Symbiotic therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symbiotic group<br>Jaundiced patients who have symbiotic therapy | Dietary Supplement: Symbiotic therapy<br>* 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).<br>* Other names: Prebiotic® (Mediabase s.r.l., Prato, Italy);|
| No Symbiotic therapy<br>Jaundiced patients who not have symbiotic therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious Morbidity Rate |  | 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 |  | 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 | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, jaundice, symbiotic, translocation, abdominal collection, morbidity