Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166868
First received: September 12, 2005
Last updated: August 19, 2013
Last verified: August 2013

September 12, 2005
August 19, 2013
December 2003
January 2012   (final data collection date for primary outcome measure)
episodes of cholangitis [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
episodes of cholangitis during 6 months of intervention
episodes of cholangitis
Complete list of historical versions of study NCT00166868 on ClinicalTrials.gov Archive Site
gain of body weight [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
the change of z-score of body weight after 6 months of intervention
gain of body weight
Not Provided
Not Provided
 
Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
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 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 (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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Biliary Atresia
  • Drug: Lactobacillus casei rhamnosus (Lcr35)
  • Drug: Neomycin
  • Experimental: Neomycin prescribed
    Interventions: 10 cases received Neomycin for 6 months
    Intervention: Drug: Neomycin
  • Experimental: Probiotics (Lactobacillus casei rhamnosus, Lcr35) prescribed
    Interventions: 10 cases received Probiotics for 6 months
    Intervention: Drug: Lactobacillus casei rhamnosus (Lcr35)
  • No Intervention: control
    10 cases without intervention were historical control.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • The patients who had received liver transplantation
Both
4 Months to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00166868
921201
Not Provided
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Mei-Hwei Chang, Professor National Taiwan University
National Taiwan University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP