Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
Primary Purpose
Biliary Atresia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lactobacillus casei rhamnosus (Lcr35)
Neomycin
Sponsored by
About this trial
This is an interventional prevention trial for Biliary Atresia focused on measuring Biliary atresia, cholangitis, probiotics, prophylaxis
Eligibility Criteria
Inclusion Criteria: Biliary atresia patients aged 0 to 3 years, who had a Kasai operation Exclusion Criteria: The patients who had received liver transplantation
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Neomycin prescribed
Probiotics (Lactobacillus casei rhamnosus, Lcr35) prescribed
control
Arm Description
Interventions: 10 cases received Neomycin for 6 months
Interventions: 10 cases received Probiotics for 6 months
10 cases without intervention were historical control.
Outcomes
Primary Outcome Measures
episodes of cholangitis
episodes of cholangitis during 6 months of intervention
Secondary Outcome Measures
gain of body weight
the change of z-score of body weight after 6 months of intervention
Full Information
NCT ID
NCT00166868
First Posted
September 12, 2005
Last Updated
August 19, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00166868
Brief Title
Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
Official Title
Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
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 (TMP/SMZ) 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 mg/kg/d, qid, 4 days a week). Another 10 patients receive Lactobacillus casei rhamnosus, Lcr 35 (8x108 CFU/day, 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 (TMP/SMZ) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia
Keywords
Biliary atresia, cholangitis, probiotics, prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neomycin prescribed
Arm Type
Experimental
Arm Description
Interventions: 10 cases received Neomycin for 6 months
Arm Title
Probiotics (Lactobacillus casei rhamnosus, Lcr35) prescribed
Arm Type
Experimental
Arm Description
Interventions: 10 cases received Probiotics for 6 months
Arm Title
control
Arm Type
No Intervention
Arm Description
10 cases without intervention were historical control.
Intervention Type
Drug
Intervention Name(s)
Lactobacillus casei rhamnosus (Lcr35)
Intervention Type
Drug
Intervention Name(s)
Neomycin
Primary Outcome Measure Information:
Title
episodes of cholangitis
Description
episodes of cholangitis during 6 months of intervention
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
gain of body weight
Description
the change of z-score of body weight after 6 months of intervention
Time Frame
6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biliary atresia patients aged 0 to 3 years, who had a Kasai operation
Exclusion Criteria:
The patients who had received liver transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Hwei Chang, Professor
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25534776
Citation
Lien TH, Bu LN, Wu JF, Chen HL, Chen AC, Lai MW, Shih HH, Lee IH, Hsu HY, Ni YH, Chang MH. Use of Lactobacillus casei rhamnosus to Prevent Cholangitis in Biliary Atresia After Kasai Operation. J Pediatr Gastroenterol Nutr. 2015 May;60(5):654-8. doi: 10.1097/MPG.0000000000000676.
Results Reference
derived
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Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
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