Effectiveness Of Symbiotic Therapy In Jaundiced Patients
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial|
- Infectious Morbidity Rate [ Time Frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks ] [ Designated as safety issue: Yes ]
- IMMUNE PROFILE [ Time Frame: The day before and on postoperative day 7 ] [ Designated as safety issue: Yes ]
- RATE OF TRANSLOCATION [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture
|Study Start Date:||November 2008|
Jaundiced patients who have symbiotic therapy
Dietary Supplement: 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 Name: Prebiotic® (Mediabase s.r.l., Prato, Italy)
No Symbiotic therapy
Jaundiced patients who not have symbiotic therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683708
|Principal Investigator:||Lorenzo Capussotti, MD||Mauriziano Hospital, Department of General and Oncological surgery|