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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01683708
Other study ID # Symbiotic2012
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 7, 2012
Last updated September 10, 2012
Start date November 2008

Study information

Verified date September 2012
Source Azienda Ospedaliera Ordine Mauriziano di Torino
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Ordine Mauriziano di Torino

References & Publications (2)

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 — View Citation

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):706-1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Infectious Morbidity Rate Participants will followed for the duration of hospital stay, an expected average of 6 weeks Yes
Secondary IMMUNE PROFILE The day before and on postoperative day 7 Yes
Secondary RATE OF TRANSLOCATION a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture Intraoperative Yes
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