Effectiveness Of Symbiotic Therapy In Jaundiced Patients

Azienda Ospedaliera Ordine Mauriziano di Torino

Status: Unknown

Conditions: Jaundice; Postoperative Infections

Treatments: Dietary Supplement: Symbiotic therapy

Study type: Observational

Funder types: Other

Identifiers

NCT01683708

Symbiotic2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

20 participants in 2 patient groups

Symbiotic group

Description:

Jaundiced patients who have symbiotic therapy

Treatment:

Dietary Supplement: Symbiotic therapy

No Symbiotic therapy

Description:

Jaundiced patients who not have symbiotic therapy