Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Biliary Atresia
Intervention: Lactobacillus casei rhamnosus (Lcr35) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Mei-Hwei Chang, Professor, Principal Investigator, Affiliation: National Taiwan University
Overall contact:
Mei-Hwei Chang, Professor, Phone: 886-2-23123456, Ext: 5131, Email: mhchang@ha.mc.ntu.edu.tw
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 18 BA patients,
from 1991 to 1996, aged 0 to 3 years, with cholangitis but not put on long-term prophylaxis
after portoenterostomy, served as the historical control group. Comparisons of the episodes
of cholangitis, time to the first episode, growth and development, liver functions and
survival rates are made among the three groups.
Clinical Details
Official title: Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia
Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: episodes of cholangitis
Secondary outcome: gain of body weight
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.
Eligibility
Minimum age: 1 Month.
Maximum age: 3 Years.
Gender(s): Both.
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
Locations and Contacts
Mei-Hwei Chang, Professor, Phone: 886-2-23123456, Ext: 5131, Email: mhchang@ha.mc.ntu.edu.tw
National Taiwan University Hospital, Taipei, Taiwan; Recruiting
Mei-Hwei Chang, Profesor, Phone: 886-2-23123456, Ext: 5131, Email: mhchang@ha.mc.ntu.edu.tw
Mei-Hwei Chang, Professor, Principal Investigator
Additional Information
Starting date: December 2003
Last updated: September 12, 2005
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