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Effect of probiotic in pediatric cholestatic liver disease

Effect of probiotic (Lactobacilus sporogenesis) in reducing PELD score in pediatric cholestatic liver disease:Randomized double blinded clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200628047940N1
Enrollment
120
Registered
2020-07-21
Start date
2020-08-05
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Cholestatic liver disease in children.

Interventions

Intervention 1: Intervention group: The treatment group will be received Lactobacilus sporogenesis probiotic is given in drops for 1 month (5 drops per day in two intervals). Intervention 2: Control g

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: age1-12 cholestatic liver failure informed consent

Exclusion criteria

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 150 meq / dl, serum potassium 5.5 meq / dl) History of Allergies

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Motazedian

Shiraz University of Medical Sciences

motazediann@yahoo.com+98 71 3628 1529

Outcome results

None listed

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