Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164099
Status:
TERMINATED
Last Update Posted:
2007-11-01
First Post:
2005-09-09
Brief Title:
The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery A Pilot Study
Sponsor:
Beth Israel Medical Center
Organization:
Beth Israel Medical Center
Study Overview
Official Title:
The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery A Pilot Study
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients would not take product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All surgical procedures carry with them the risk of infection Even a minor infection can extend the hospitalization after cardiac surgery The average minimum increase in length of stay for a single infection is three days
One of the many means used to reduce post-operative infections is the preventative or prophylactic administration of antibiotics just before and just after surgery Because antibiotics and for that matter surgery itself alter the bodys natural immune and inflammatory responses and the makeup of the bacteria in the intestine there is a great deal of scientific interest in using the supplementation of bacteria that naturally reside in the intestine It is felt that by doing so the alterations in the immune response may be corrected and the patient better able to fight infections There are studies using probiotics that have demonstrated a reduction in infection rates in patients undergoing abdominal surgery
Subjects will be patients at high risk for infection including those with any one or more of the following characteristics over 65 years old poor heart function ejection fraction 40 diabetes insulin dependant or non-insulin dependant peripheral vascular disease kidney dysfunction creatinine level 2mgdl obesity body surface area 2 m2 low serum protein levels albumin 25 mgdl infection of the heart valve endocarditis or on any antibiotics other than standard prophylaxis before surgery
The safety of these products has been very well established
Patients who consent to enter the study will receive the synbiotic mix or a placebo which comes in a powder that may be mixed with a drink or washed down into the stomach through the NG tube if the patient is still on a ventilator Dosing will be initiated within four hours of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice daily basis for the duration of their admission days Infection and diarrhea data will be monitored
One of the many means used to reduce post-operative infections is the preventative or prophylactic administration of antibiotics just before and just after surgery Because antibiotics and for that matter surgery itself alter the bodys natural immune and inflammatory responses and the makeup of the bacteria in the intestine there is a great deal of scientific interest in using the supplementation of bacteria that naturally reside in the intestine It is felt that by doing so the alterations in the immune response may be corrected and the patient better able to fight infections There are studies using probiotics that have demonstrated a reduction in infection rates in patients undergoing abdominal surgery
Subjects will be patients at high risk for infection including those with any one or more of the following characteristics over 65 years old poor heart function ejection fraction 40 diabetes insulin dependant or non-insulin dependant peripheral vascular disease kidney dysfunction creatinine level 2mgdl obesity body surface area 2 m2 low serum protein levels albumin 25 mgdl infection of the heart valve endocarditis or on any antibiotics other than standard prophylaxis before surgery
The safety of these products has been very well established
Patients who consent to enter the study will receive the synbiotic mix or a placebo which comes in a powder that may be mixed with a drink or washed down into the stomach through the NG tube if the patient is still on a ventilator Dosing will be initiated within four hours of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice daily basis for the duration of their admission days Infection and diarrhea data will be monitored
Detailed Description:
Background
Despite progress in surgical methodology infections remain one of the most difficult post-operative complications to prevent In cardiac surgery the presence of an infection can make the difference between a brief hospital stay and a life-threatening illness The average minimum increase in length of stay due to a single infection is three days and can extend to months Nationally the average rate of deep sternal wound infection is 3 and conduit harvest site infection 14
Because of the intimate relationship between intestinal bacterial flora and normal gut and immunologic function current research is investigating the relationship between the preservation or augmentation of certain naturally occurring bacterial strains in the intestine and clinical outcomes particularly infectious We propose to examine the efficacy of immediate post-operative supplementation with a product containing four bacterial strains and four different fibers putatively fuel for bacterial growth in reducing infections
Until recently most studies performed with LAB have selected strains for their palatability and usability in yogurts For this reason most studies have been based on LAB such as Lactobacillus acidophilus Lcasei L delbrueckii och Bifidobacillus adolescentis Bbifidum Blongum and Bifidobacterium infantis which are common in yogurts and kefirs It is only recently that interest has been focused on developing criteria for selecting LAB based on intraluminal biology such as the ability to adhere to mucus or mucosal cells the ability to ferment resistant fibers and antioxidant capacity For example Lplantarum which is often recovered from fermented fruits vegetables sourdoughs and silage has been demonstrated to have a strong ability to adhere to mucosa and to break down resistant fibers L plantarum is the commonest LAB in human gastrointestinal tract and has shown the greatest ability of all LAB tested to survive in the gut 106 times that of Lrhamnosus for example and activate cytokine secretion after passage through the stomach and the small intestine
The clinical impact of a particular LAB is strongly associated with its ability to colonize the intestinal mucosa LAB common in dairy products such as yogurts LAcidophilus Lbulgaris and bifidobacteria have very limited ability to colonize intestinal mucosal cells Lrhamnosus GG and even more so Lplantarum 299 have been shown to remain viable up to 28 days post supplementation Lplantarum is unique as it uses carbohydrate receptors mannose similar to those of gram-negative bacteria Ecoli Enterobacter Klebsiella Salmonella Shigella Pseudomonas and Vibrio cholerae L plantarum has also been shown to prevent adhesion of enteropathogenic Ecoli through induction of mRNA expression for the intestinal mucins MUC2 and MUC3
Design of the present study 75 consecutive patients deemed at high risk for post-operative infection will be prospectively and blindly randomized to one of the following three groups
1 Lactic acid bacteria and fermentable fiber
2 Fermentable fiber alone
3 Non-fermentable placebo
Sachets containing LAB plus fiber fiber alone or placebo will be provided by the manufacturer and will be randomized coded and assigned to patients in order Patients will begin receiving doses within 4 hours of arrival to the CSICU and will remain on treatment twice daily for 14 days
Data collection Infection control data are collected on all patients undergoing cardiac surgery using established institutional definitions for infections Incidence of sternal infections donor site infections vein harvest site infection pneumonia urinary tract infection catheter and blood stream infections and clostridium difficile colitis will be considered In addition the incidence of diarrhea defined as stools of liquid or gelatinous consistency or more than three stools in one day will be monitored Data will be collected during hospital stay and at one-month follow-up Finally C-reactive protein levels which are commonly assessed during hospitalizations and used as part of the assessment for coronary risk will be drawn pre-operatively and four days post-operatively
Despite progress in surgical methodology infections remain one of the most difficult post-operative complications to prevent In cardiac surgery the presence of an infection can make the difference between a brief hospital stay and a life-threatening illness The average minimum increase in length of stay due to a single infection is three days and can extend to months Nationally the average rate of deep sternal wound infection is 3 and conduit harvest site infection 14
Because of the intimate relationship between intestinal bacterial flora and normal gut and immunologic function current research is investigating the relationship between the preservation or augmentation of certain naturally occurring bacterial strains in the intestine and clinical outcomes particularly infectious We propose to examine the efficacy of immediate post-operative supplementation with a product containing four bacterial strains and four different fibers putatively fuel for bacterial growth in reducing infections
Until recently most studies performed with LAB have selected strains for their palatability and usability in yogurts For this reason most studies have been based on LAB such as Lactobacillus acidophilus Lcasei L delbrueckii och Bifidobacillus adolescentis Bbifidum Blongum and Bifidobacterium infantis which are common in yogurts and kefirs It is only recently that interest has been focused on developing criteria for selecting LAB based on intraluminal biology such as the ability to adhere to mucus or mucosal cells the ability to ferment resistant fibers and antioxidant capacity For example Lplantarum which is often recovered from fermented fruits vegetables sourdoughs and silage has been demonstrated to have a strong ability to adhere to mucosa and to break down resistant fibers L plantarum is the commonest LAB in human gastrointestinal tract and has shown the greatest ability of all LAB tested to survive in the gut 106 times that of Lrhamnosus for example and activate cytokine secretion after passage through the stomach and the small intestine
The clinical impact of a particular LAB is strongly associated with its ability to colonize the intestinal mucosa LAB common in dairy products such as yogurts LAcidophilus Lbulgaris and bifidobacteria have very limited ability to colonize intestinal mucosal cells Lrhamnosus GG and even more so Lplantarum 299 have been shown to remain viable up to 28 days post supplementation Lplantarum is unique as it uses carbohydrate receptors mannose similar to those of gram-negative bacteria Ecoli Enterobacter Klebsiella Salmonella Shigella Pseudomonas and Vibrio cholerae L plantarum has also been shown to prevent adhesion of enteropathogenic Ecoli through induction of mRNA expression for the intestinal mucins MUC2 and MUC3
Design of the present study 75 consecutive patients deemed at high risk for post-operative infection will be prospectively and blindly randomized to one of the following three groups
1 Lactic acid bacteria and fermentable fiber
2 Fermentable fiber alone
3 Non-fermentable placebo
Sachets containing LAB plus fiber fiber alone or placebo will be provided by the manufacturer and will be randomized coded and assigned to patients in order Patients will begin receiving doses within 4 hours of arrival to the CSICU and will remain on treatment twice daily for 14 days
Data collection Infection control data are collected on all patients undergoing cardiac surgery using established institutional definitions for infections Incidence of sternal infections donor site infections vein harvest site infection pneumonia urinary tract infection catheter and blood stream infections and clostridium difficile colitis will be considered In addition the incidence of diarrhea defined as stools of liquid or gelatinous consistency or more than three stools in one day will be monitored Data will be collected during hospital stay and at one-month follow-up Finally C-reactive protein levels which are commonly assessed during hospitalizations and used as part of the assessment for coronary risk will be drawn pre-operatively and four days post-operatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None