Biliary atresia Biliary atresia ,Postoperative cholangitis
Conditions
Interventions
Oral administration of kestose (a prebiotic fructooligosaccharide).
D005507
Kestose, Fructooligosaccharides, Probiotics
Sponsors
Inoue Mikihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the gut microbiota composition (assessed using the Chao1 richness estimator and the Shannon diversity index) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactAtsuki Naoe
Fujita Health University
Outcome results
None listed