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New treatment option for Biliary Atresia
Official title Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy
ClinicalTrials.gov ID: NCT05925309
What this study is testing
What is Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem?
Basic treatment: sulperazone + ursodeoxycholic acid + compound glycyrrhizin + methylprednisolone + vitamin AD , D , E , K + imipenem or meropenem is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for biliary atresia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 90
You may be able to join if
- 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;
You likely can't join if
- Patients with cholestasis of non-BA disease;
- Patients who have undergone KP at other institutions;
- Patients whose pathohistological diagnosis is in doubt;
- Patients who undergo liver transplantation immediately after KP;
- Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.)...
- Patients with severe cardiac, renal, or central nerve system malformations (e.g., tetralogy of Fallot, transposition of the great arteries, cerebral...
See the full eligibility criteria
- 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.
- Patients with cholestasis of non-BA disease;
- Patients who have undergone KP at other institutions;
- Patients whose pathohistological diagnosis is in doubt;
- Patients who undergo liver transplantation immediately after KP;
- Patients with other liver diseases or severe complications (e.g., severe pulmonary hypertension, renal failure, intracranial hemorrhage, etc.) requiring surgical intervention or other medical therapy;
- Patients with severe cardiac, renal, or central nerve system malformations (e.g., tetralogy of Fallot, transposition of the great arteries, cerebral dysplasia, etc.) and have poor prognosis;
- Patients judged by the researchers that they can not comply with the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 days to 90 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.