NIPH Clinical Trials Search

Prebiotics to improve gut bacteria balance and prevent cholangitis after surgery for biliary atresia

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Biliary atresia
Date of first enrollment	29/05/2026
Target sample size	15
Countries of recruitment
Study type	Interventional
Intervention(s)	Oral administration of kestose (a prebiotic fructooligosaccharide).

Outcome(s)

Primary Outcome

Changes in the gut microbiota composition (assessed using the Chao1 richness estimator and the Shannon diversity index)

Secondary Outcome

Blood tests: inflammatory markers WBC CRP PCT liver function tests total bilirubin direct bilirubin AST ALT GGT coagulation parameters platelet count PLT prothrombin time PT activated partial thromboplastin time APTT Adverse events including diarrhea abdominal pain and other symptoms Change in the incidence rate of cholangitis compared with the pre observation period frequency of cholangitis episodes

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who have provided written informed consent after receiving sufficient explanation and having adequate understanding of the study with consent obtained from the patient when appropriate and from a legally authorized representative and assent obtained when applicable and patients with biliary atresia who have undergone surgery and required outpatient or inpatient treatment at the Department of Pediatric Surgery Fujita Health University Hospital for postoperative cholangitis within the past five years and patients who are considered by the principal investigator to be able to undergo the required evaluations during the study period including clinical assessments laboratory examinations and follow up.
Exclude criteria	Patients who are in the acute phase of cholangitis at study entry, or in whom cholangitis is strongly suspected and who are judged to require immediate treatment.Patients with a known hypersensitivity to the prebiotics used in this study, or those with a history suggestive of serious adverse reactions to such agents.Patients with severe comorbidities (e.g., severe hepatic dysfunction, severe renal dysfunction, severe cardiac disease, immunodeficiency, or severe infections) that may raise safety concerns for participation in this study.Patients who are scheduled to receive or are currently receiving treatments that may significantly affect the continuation of the intervention or the evaluation of outcomes (e.g., intensive immunosuppressive therapy, participation in other interventional studies).Patients with conditions that may affect the gut microbiota, such as inflammatory bowel disease, immunodeficiency disorders, or those receiving immunosuppressive therapy.Patients who are otherwise deemed inappropriate for participation in the study by the principal investigator or sub-investigators.