Effectiveness Of Symbiotic Therapy In Jaundiced Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Azienda Ospedaliera Ordine Mauriziano di Torino.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
LorenzoCapussotti, Azienda Ospedaliera Ordine Mauriziano di Torino
ClinicalTrials.gov Identifier:
NCT01683708
First received: September 7, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Postoperative Infections
Jaundice
Dietary Supplement: Symbiotic therapy

Study Type: Observational
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

Further study details as provided by Azienda Ospedaliera Ordine Mauriziano di Torino:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: November 2008
Groups/Cohorts Assigned Interventions
Symbiotic group
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Jaundiced patients scheduled for hepato-biliary pancreatic surgery

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01683708

Sponsors and Collaborators
Azienda Ospedaliera Ordine Mauriziano di Torino
Investigators
Principal Investigator: Lorenzo Capussotti, MD Mauriziano Hospital, Department of General and Oncological surgery
  More Information

Publications:
Responsible Party: LorenzoCapussotti, Director of Department of General and Oncologica Surgery, Azienda Ospedaliera Ordine Mauriziano di Torino
ClinicalTrials.gov Identifier: NCT01683708     History of Changes
Other Study ID Numbers: Symbiotic2012
Study First Received: September 7, 2012
Last Updated: September 10, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Ordine Mauriziano di Torino:
sepsis
jaundice
symbiotic
translocation
abdominal collection
morbidity

Additional relevant MeSH terms:
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014