Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
Condition: Biliary Atresia
MeSH terms: Cholangitis; Biliary Atresia
Study type: Interventional

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.
    

Intervention name(s): Lactobacillus casei rhamnosus (Lcr35); Neomycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Neomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Biliary atresia, cholangitis, probiotics, prophylaxis