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Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2025 to Dec 31, 2027
    • Study completion date: Jul 31, 2027 to Dec 31, 2029
    • Secondary endpoints: details revised at 2 of 12 entries
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Study completion date: Jun 30, 2027 to Jul 31, 2027
    • Start date changed from estimate of Jun 28, 2023 to Jul 1, 2023
    • Secondary endpoints: details revised at 4 of 12 entries
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05925309
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Biliary Atresia, Cholangitis, Anti-Bacterial Agents
Related terms Biliary Atresia, Cholangitis
Enrollment 356 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov