Effect of probiotic in pediatric cholestatic liver disease

Phase 3

Recruiting

Conditions: Cholestatic liver disease in children.

Registration Number: IRCT20200628047940N1

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

age1-12
cholestatic liver failure
informed consent

Exclusion Criteria

Taking antibiotics for four weeks before the study
Active microbial infection
History of gastrointestinal bleeding over the past two months
History of SBP over the past two months
Taking immunosuppressive drugs
Immunosuppressed patients
Renal failure ( creatinine> 1.5 mg)
Electronic imbalance (serum sodium <130 or> 150 meq / dl, serum potassium <3.0 or> 5.5 meq / dl)
History of Allergies

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Pediatric End-Stage Liver Disease (PELD) score. Timepoint: The results of Lab test for calculation of Pediatric End-Stage Liver Disease (PELD) score will be evaluated one month, three months after finishing the intervention. Method of measurement: Pediatric End-Stage Liver Disease (PELD) Score = 0.480 × Loge (bilirubin mg/dL) + 1.857 × Loge (INR) - 0.687 × Loge (albumin g/dL) + 0.436 (if the patient is less than 1 year old) + 0.667 if the patient has growth failure (< -2 Standard deviation). Then multiply the score by 10 and round to the nearest whole number.

Secondary Outcome Measures

Name	Time	Method
Improvement in growth and development. Timepoint: Three months after finishing the study. Method of measurement: Measuring weight by scale and height by stadiometer.