Official Title: “Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Lactobacillus casei rhamnosus (Lcr35)

Primary Measures

• episodes of cholangitis

Secondary Measures

• gain of body weight

Inclusion Criteria:

• Biliary atresia patients aged 0 to 3 years, who had a Kasai operation

Exclusion Criteria:

• The patients who had received liver transplantation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 3 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Taiwan University Hospital

Overall Clinical Trial Officials and Contacts

Mei-Hwei Chang, Professor Principal Investigator National Taiwan University  

Overall Contact: Mei-Hwei Chang, Professor 886-2-23123456 mhchang@ha.mc.ntu.edu.tw

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00166868

Study ID Number: 921201

ClinicalTrials.gov Identifier: NCT00166868

Health Authority: Taiwan: Department of Health