Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166868
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2005-09-12
Brief Title:
Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abstract
Biliary atresia BA is an idiopathic progressive and fatal disease if untreated Since Kasai first introduced the operation for BA in 1959 there have been encouraging results in treating this disease Ascending cholangitis is a frequent and often recurrent complication It may worsen the prognosis with an increase in mortality secondary failure of restoration of bile flow and possible exacerbation of portal hypertension For patients who have had restoration of bile flow with a timely portoenterostomy the recurrence of ascending cholangitis is the single most significant variable pertaining to long-term prognosis Patients with multiple episodes of ascending cholangitis are more likely to require liver transplantation than those without multiple recurrences Therefore the prevention of cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy
Some oral antibiotics like trimethoprim-sulfamethoxazole TMPSMZ and neomycin have showed the effect to prevent against ascending cholangitis But we should consider the problem of drug resistance after long-term use of antibiotics Is there any better and safer treatment Probiotics are live microorganisms which have beneficial effects on human health Many studies have showed that probiotics have effects to treat or prevent intestinal infection or inflammation even for patient after liver transplantation The aim of this study is to investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis
We want to enroll 20 BA patients aged 0 to 3 years who had a Kasai operation Ten patients are treated with neomycin 25 mgkgd qid 4 days a week Another 10 patients receive Lactobacillus casei rhamnosus Lcr 35 8x108 CFUday bid The duration of treatment is 6 months Bacterial cultures of stool are performed before treatment and 1 month 3 months and 6 months after treatment to evaluate the change of intestinal flora Another 10 BA patients from 1991 to 1996 aged 0 to 3 years without prophylaxis after portoenterostomy were served as the historical control group Comparisons of the episodes of cholangitis time to the first episode and body weight change are made among the three groups
Biliary atresia BA is an idiopathic progressive and fatal disease if untreated Since Kasai first introduced the operation for BA in 1959 there have been encouraging results in treating this disease Ascending cholangitis is a frequent and often recurrent complication It may worsen the prognosis with an increase in mortality secondary failure of restoration of bile flow and possible exacerbation of portal hypertension For patients who have had restoration of bile flow with a timely portoenterostomy the recurrence of ascending cholangitis is the single most significant variable pertaining to long-term prognosis Patients with multiple episodes of ascending cholangitis are more likely to require liver transplantation than those without multiple recurrences Therefore the prevention of cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy
Some oral antibiotics like trimethoprim-sulfamethoxazole TMPSMZ and neomycin have showed the effect to prevent against ascending cholangitis But we should consider the problem of drug resistance after long-term use of antibiotics Is there any better and safer treatment Probiotics are live microorganisms which have beneficial effects on human health Many studies have showed that probiotics have effects to treat or prevent intestinal infection or inflammation even for patient after liver transplantation The aim of this study is to investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis
We want to enroll 20 BA patients aged 0 to 3 years who had a Kasai operation Ten patients are treated with neomycin 25 mgkgd qid 4 days a week Another 10 patients receive Lactobacillus casei rhamnosus Lcr 35 8x108 CFUday bid The duration of treatment is 6 months Bacterial cultures of stool are performed before treatment and 1 month 3 months and 6 months after treatment to evaluate the change of intestinal flora Another 10 BA patients from 1991 to 1996 aged 0 to 3 years without prophylaxis after portoenterostomy were served as the historical control group Comparisons of the episodes of cholangitis time to the first episode and body weight change are made among the three groups
Detailed Description:
Biliary atresia BA is an idiopathic progressive and fatal disease if untreated Since Kasai first introduced the operation for BA in 1959 there have been encouraging results in treating this disease Ascending cholangitis is a frequent and often recurrent complication It may worsen the prognosis with an increase in mortality secondary failure of restoration of bile flow and possible exacerbation of portal hypertension For patients who have had restoration of bile flow with a timely portoenterostomy the recurrence of ascending cholangitis is the single most significant variable pertaining to long-term prognosis Patients with multiple episodes of ascending cholangitis are more likely to require liver transplantation than those without multiple recurrences Therefore the prevention of cholangitis is crucial in the management of patients who have had a Kasai portoenterostomy
Some oral antibiotics like trimethoprim-sulfamethoxazole TMPSMZ and neomycin have showed the effect to prevent against ascending cholangitis But we should consider the problem of drug resistance after long-term use of antibiotics Is there any better and safer treatment Probiotics are live microorganisms which have beneficial effects on human health Many studies have showed that probiotics have effects to treat or prevent intestinal infection or inflammation even for patient after liver transplantation The aim of this study is to investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis
Some oral antibiotics like trimethoprim-sulfamethoxazole TMPSMZ and neomycin have showed the effect to prevent against ascending cholangitis But we should consider the problem of drug resistance after long-term use of antibiotics Is there any better and safer treatment Probiotics are live microorganisms which have beneficial effects on human health Many studies have showed that probiotics have effects to treat or prevent intestinal infection or inflammation even for patient after liver transplantation The aim of this study is to investigate the possibility of use of probiotics in prophylaxis of ascending cholangitis
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