Effectiveness Of Symbiotic Therapy In Jaundiced Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
Jaundiced patients scheduled for hepato-biliary pancreatic surgery
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
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 May 16, 2013