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The efficacy of folic acid in preventing postoperative cholangitis of patients with biliary atresia: a randomized, double-blind, placebo-controlled parallel singel center clinical trial

The efficacy of folic acid in preventing postoperative cholangitis of patients with biliary atresia: a randomized, double-blind, placebo-controlled parallel singel center clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063603
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-09-12
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia

Interventions

Trial group:Folic acid
Placebo:Placebo

Sponsors

Guangzhou Women and Children Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.3 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with BA and treated with Kasai procedure.The enrolled subjects should meet the following inclusion criteria: 1) Biliary atresia (BA) is definitely diagnosed by operation, and hepaticojejunostomy (Kasai procedure) is successfully conducted. 2) The age at operation is < 90 days 3) Parents or guardians sign informed consent.

Exclusion criteria

Exclusion criteria: Excluded subjects must meet one of the following exclusion criteria: 1)Anemia, epilepsy and other neurological diseases with unknown reasons; 2)Accompanied by severe deformities or infections and metabolic diseases; 3)Family members (especially the mother) have a history of folate allergy;

Design outcomes

Primary

MeasureTime frame
Survival time without cholangitis;

Secondary

MeasureTime frame
liver function index;ultrasound;Blood folate level;microelement;

Countries

China

Contacts

Public ContactZhe Wen

Guangzhou Women and Children Medical Center

wenzhe2005@163.com18902268782

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026