An interventional study of Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem and Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor in Biliary Atresia, Cholangitis and Anti-Bacterial Agents, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 14 Days to 90 Days. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Prevention
This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.
Biliary atresia (BA) is a devastating inflammatory obstructive neonatal disease affecting intrahepatic and extrahepatic bile ducts. Kasai portoenterostomy (KP) is the mainstay of treatment for BA. Cholangitis is a common complication after KP, with an overall incidence of 22-93%, and an incidence of 30-70% within 6 months after KP. The mechanism of cholangitis may be intestinal bacteria ascending into the intrahepatic biliary system or bacterial colonization, etc. Common causative organisms include Klebsiella, Escherichia coli, Pseudomonas aeruginosa, Enterobacter cloacae, Acinetobacter baumannii, Streptococcus, and Salmonella typhi. There is some controversy about prophylactic antibiotics after KP, and the type, dosage and course of antibiotics in medical institutions around the world vary greatly. After years of improvement, although the postoperative management and short-term prognosis of BA have improved, the overall incidence of cholangitis has not changed much. High-quality evidence for antibiotic prophylaxis after KP remains lacking. It still remains unknown that whether long-term prophylactic oral antibiotics could benefit the patients. Long-term use of antibiotics may not only increase the burden of liver dysfunction in patients, but also lead to antibiotic resistance, intestinal flora disturbance, and increase the risk of allergies and autoimmune diseases. It is of great significance to use evidence-based medicine to find a relatively reasonable cholangitis prevention program.
This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics after KP and those who did not. Patients diagnosed with type III BA and receiving KP at Children's Hospital of Fudan University will be assigned to 2 groups. Both groups received the same basic treatment, then the patients in the antibiotics group received prophylactic oral antibiotics until the 6th month after KP, while the non-antibiotics group no longer used prophylactic antibiotics until cholangitis occurred. The cholangitis rate within 6 months after KP were measured to evaluate the preventive effect of prophylactic oral antibiotics on cholangitis. The patients were followed up for 2 years after KP.
77 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's planned enrollment of 356 is above the median of 45 across 43 interventional studies indexed under Biliary Atresia.
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Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Basic treatment + Prophylactic oral antibiotics
Drug: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem · Drug: Prophylactic oral antibiotics: compound sulfamethoxazole tablet (SMZ/TMP) + cefaclor
Basic treatment
Drug: Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem
Sulperazone 50mg/kg q8h is used intravenously from the first day to the 14th day after KP surgery. Ursodeoxycholic acid 20mg/kg/d p.o, starting from the 5th day after surgery for at least 2 years. Compound glycyrrhizin 20mg/d i.v, 1-4 days after operation, then switch to compound glycyrrhizin tablets 12.5mg b.i.d p.o until 6 months after KP. Methylprednisolone start at 4mg/kg/d i.v on the 8th day after operation, and decrease by 1mg/kg/d every three days. Starting at about the 15th day after operation, methylprednisolone 4mg/kg is given orally every other day, and the dose is gradually reduced at 10-12 weeks. Vitamin AD , D , E , K, are given orally from the 5th day after the KP for at least 2 months. Treatment of cholangitis: sulperazone 50mg/kg q8h i.v., and methylprednisolone could be used. If cholangitis is not controlled, imipenem or meropenem may be used.
Compound sulfamethoxazole tablet (SMZ/TMP) 25 mg/kg/d p.o. and cefaclor 12.5 mg/kg/d p.o. alternately every 2 weeks, from post-operation day 15 to month 6.
The occurrence of cholangitis (confirmed or suspected) within 6 months after KP
Definition of cholangitis: A. Clinical elements 1. Fever and/or shivering; 2. Stool color change; 3. New/increasing jaundice; 4. Abdominal discomfort: vomiting, poor, feeding, irritability. B. Laboratory and imaging elements 1. Inflammatory response (WBC and/or CRP and/or PCT); 2. Increased/increasing transaminases; 3. Increased/increasing GGT and/or bilirubin; 4. Bile lakes. Suspected cholangitis: one item in A + one item in B. Confirmed cholangitis: two items in A + two items in B or "suspected cholangitis" + positive blood culture. The diagnosis of cholangitis requires the exclusion of definite infections of other systems.
Time frame: 6 months after KP
The occurrence of cholangitis (confirmed or suspected) within 1 year after KP
The definition of cholangitis is the same as primary outcome.
Time frame: 1 year after KP
The occurrence of jaundice clearance within 6 months after KP
Jaundice clearance is defined as total bilirubin (TB) less than 20 μmol/L.
Time frame: 6 months after KP
The occurrence of jaundice clearance within 1 year after KP
Jaundice clearance is defined as TB less than 20 μmol/L.
Time frame: 1 year after KP
The number of cholangitis recurrence within 6 months after KP
The definition of cholangitis is the same as primary outcome.
Time frame: 6 months after KP
The number of cholangitis recurrence within 1 year after KP
The definition of cholangitis is the same as primary outcome.
Time frame: 1 year after KP
The patient survive with native liver or not within 2 years after KP
Time frame: 2 years after KP
The weight gain of the patients from pre-operation to 6 months post KP
Weight for height (length) Z-score is calculated based on the gender, age, and weight reference standards for children in China. The difference in weight for height (length) Z-score between pre-operation and 6 months post KP is regarded as weight gain.
Time frame: From pre-operation to 6 months post KP
The weight gain of the patients from pre-operation to 1 year post KP
Weight for height (length) Z-score is calculated based on the gender, age, and weight reference standards for children in China. The difference in weight for height (length) Z-score between pre-operation and 1 year post KP is regarded as weight gain.
Time frame: From pre-operation to 1 year post KP
Liver parameters at post-operation month 6
Liver parameters: pediatric end-stage liver disease (PELD) score, liver stiffness measurement. PELD score = \[0.480×ln (total bilirubin) + 1.857×ln (international normalized ratio)-0.687×ln (albumin) + 0.436 × age score + 0.667 × growth arrest\] × 10. Age score:1 point for age \< 24 months, 0 for age ≥ 24 months. Growth arrest: 1 point for more than 2 standard deviations below the average, otherwise 0. Liver stiffness measurement is measured by liver transient elastography.
Time frame: 6 months after KP
Liver parameters at post-operation month 12
Liver parameters: pediatric end-stage liver disease (PELD) score, liver stiffness measurement. PELD score = \[0.480×ln (total bilirubin) + 1.857×ln (international normalized ratio)-0.687×ln (albumin) + 0.436 × age score + 0.667 × growth arrest\] × 10. Age score:1 point for age \< 24 months, 0 for age ≥ 24 months. Growth arrest: 1 point for more than 2 standard deviations below the average, otherwise 0. Liver stiffness measurement is measured by liver transient elastography.
Time frame: 1 year after KP
Changes in intestinal flora from post-operation week 2 to month 3
Fecal samples of 40 patients in each group are collected 2 weeks and 3 months after KP, and frozen at -80℃. 16s-rDNA sequencing is used to find out the changes in intestinal flora.
Time frame: From post-operation week 2 to month 3
Changes in intestinal flora from post-operation week 2 to month 6
Fecal samples of 40 patients in each group are collected 2 weeks and 6 months after KP, and frozen at -80℃. 16s-rDNA sequencing is used to find out the changes in intestinal flora.
Time frame: From post-operation week 2 to month 6
Plan to share: No
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