Effectiveness Of Symbiotic Therapy In Jaundiced Patients

• ClinicalTrials.gov Identifier: NCT01683708
• Recruitment Status: Unknown
• First Posted: September 12, 2012
• Last Update Posted: September 12, 2012
• Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
• Information provided by (Responsible Party): LorenzoCapussotti, Azienda Ospedaliera Ordine Mauriziano di Torino

Study Description

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.

Condition or disease	Intervention/treatment
Postoperative Infections; Jaundice	Dietary Supplement: 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 20 participants
• 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
• Study Start Date: November 2008

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Infectious Morbidity Rate [ Time Frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks ]

Secondary Outcome Measures :

1. IMMUNE PROFILE [ Time Frame: The day before and on postoperative day 7 ]
2. RATE OF TRANSLOCATION [ Time Frame: Intraoperative ]
   a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14.

Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. Epub 2005 Feb 12.

• Responsible Party: LorenzoCapussotti, Director of Department of General and Oncologica Surgery, Azienda Ospedaliera Ordine Mauriziano di Torino
• ClinicalTrials.gov Identifier: NCT01683708
• Other Study ID Numbers: Symbiotic2012
• First Posted: September 12, 2012
• Last Update Posted: September 12, 2012
• Last Verified: September 2012

Keywords provided by LorenzoCapussotti, Azienda Ospedaliera Ordine Mauriziano di Torino:

sepsis; jaundice; symbiotic; translocation; abdominal collection; morbidity

Additional relevant MeSH terms:

Jaundice; Hyperbilirubinemia; Pathologic Processes; Skin Manifestations