Status:
UNKNOWN
Probiotics in Pediatric Chronic Cholestasis
Lead Sponsor:
Indonesia University
Conditions:
Cholestatic Liver Disease
Eligibility:
All Genders
29-215 years
Phase:
PHASE2
PHASE3
Brief Summary
double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory exam...
Detailed Description
In mice model of cirrhosis and ascites, there is an increased intestinal permeability (leaky gut syndrome), subsequently leads to bacterial translocation. Bacterial translocation ultimately leads to b...
Eligibility Criteria
Inclusion
- diagnosed with chronic cholestasis (\>4 weeks evidence of cholestasis from laboratory evidence)
- patient/guardian give consent to participate
Exclusion
- immunocompromised
- consumed antibiotic within 2 weeks prior to recruitment time
- patient already consuming probiotic-added formula (any probiotic supplementation or formula milk with added probiotic)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04787419
Start Date
September 1 2020
End Date
December 1 2023
Last Update
March 3 2023
Active Locations (1)
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1
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430