Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 3 months
Healthy Volunteers: f
View:

• Patients whose age of operation is 14-90 d. Sex and race are not restricted;

• Patients who are born with gestational age older than 36 weeks;

• Patients whose body weight before operation \> 2 kg;

• Patients diagnosed of type-III BA and underwent KP in Children's Hospital of Fudan University;

• The type-III BA diagnosis is based on cholangiography or operation;

• Patients whose histological features of liver biopsies are reported. HE staining and Masson staining are required, and edema, inflammation, fibrosis, and hyperplasia of intrahepatic bile duct should be reported;

• Patients who are not allergic to postoperative medications;

• Patients who haven't accepted other antibiotic or probiotic therapy.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Gong Chen, Phd
chengongzlp@hotmail.com
(+86)13918330650
Backup
Di Chen
george19981206@126.com
(+86)18930942535
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 356
Treatments
Active_comparator: Antibiotics group
Basic treatment + Prophylactic oral antibiotics
Experimental: Non-antibiotics group
Basic treatment
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov