Effectiveness Of Symbiotic Therapy In Jaundiced Patients

NCT ID: NCT01683708

Last Updated: 2012-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30

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.

Conditions

Postoperative Infections; Jaundice

Keywords

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

No Symbiotic therapy

Jaundiced patients who not have symbiotic therapy

No interventions assigned to this group

Symbiotic group

Jaundiced patients who have symbiotic therapy

Symbiotic therapy

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Prebiotic® (Mediabase s.r.l., Prato, Italy)

Eligibility Criteria

Inclusion Criteria

• jaundiced patients scheduled for elective extrahepatic bile duct resections

Exclusion Criteria

• cirrhosis
• American Society of Anesthesiologists (ASA) score 4
• intestinal malabsorption
• emergency surgery
• intolerance to symbiotic
• diagnosis of primary or secondary immunodeficiency
• unresectability

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role: lead

Responsible Party

LorenzoCapussotti

Director of Department of General and Oncologica Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Capussotti, MD

Role: PRINCIPAL_INVESTIGATOR

Mauriziano Hospital, Department of General and Oncological surgery

References

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. doi: 10.1097/01.sla.0000219039.20924.88.

Reference Type: RESULT

PMID: 17060763 (View on PubMed)

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. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.

Reference Type: RESULT

PMID: 15711820 (View on PubMed)

Other Identifiers

Symbiotic2012

Identifier Type: -

Identifier Source: org_study_id