Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Biliary Atresia |
Drug: Lactobacillus casei rhamnosus (Lcr35) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia |
- episodes of cholangitis
- gain of body weight
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2003 |
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| Ages Eligible for Study: | 1 Month to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Biliary atresia patients aged 0 to 3 years, who had a Kasai operation
Exclusion Criteria:
- The patients who had received liver transplantation
Contacts and Locations| Contact: Mei-Hwei Chang, Professor | 886-2-23123456 ext 5131 | mhchang@ha.mc.ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Mei-Hwei Chang, Profesor 886-2-23123456 ext 5131 mhchang@ha.mc.ntu.edu.tw | |
| Principal Investigator: Mei-Hwei Chang, Professor | |
| Principal Investigator: | Mei-Hwei Chang, Professor | National Taiwan University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00166868 History of Changes |
| Other Study ID Numbers: | 921201 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Biliary atresia, cholangitis, probiotics, prophylaxis |
Additional relevant MeSH terms:
|
Biliary Atresia Cholangitis Bile Duct Diseases Biliary Tract Diseases |
Digestive System Diseases Digestive System Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 16, 2013