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Effectiveness Of Symbiotic Therapy In Jaundiced Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01683708
Enrollment
20
Registered
2012-09-12
Start date
2008-11-30
Completion date
Unknown
Last updated
2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Postoperative Infections

Keywords

sepsis, jaundice, symbiotic, translocation, abdominal collection, morbidity

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTSymbiotic 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).

Sponsors

Azienda Ospedaliera Ordine Mauriziano di Torino
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* jaundiced patients scheduled for elective extrahepatic bile duct resections * age between 18 and 80 year-old

Design outcomes

Primary

MeasureTime frame
Infectious Morbidity RateParticipants will followed for the duration of hospital stay, an expected average of 6 weeks

Secondary

MeasureTime frameDescription
IMMUNE PROFILEThe day before and on postoperative day 7
RATE OF TRANSLOCATIONIntraoperativea lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026