This trial is active, not recruiting.

Conditions postoperative infections, jaundice
Treatment symbiotic therapy
Sponsor Azienda Ospedaliera Ordine Mauriziano di Torino
Start date November 2008
Trial size 20 participants
Trial identifier NCT01683708, Symbiotic2012


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Jaundiced patients who have symbiotic therapy
symbiotic therapy 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).
Jaundiced patients who not have symbiotic therapy

Primary Outcomes

Infectious Morbidity Rate
time frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcomes

time frame: The day before and on postoperative day 7
time frame: Intraoperative

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
Principal investigator Lorenzo Capussotti, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Azienda Ospedaliera Ordine Mauriziano di Torino.