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Probiotics in Pediatric Chronic Cholestasis

NCT04787419 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-03

No results posted yet for this study

Summary

double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory examinations) would be compared pre vs post treatment

Conditions

  • Cholestatic Liver Disease

Interventions

OTHER

placebo

saccharum lactis

COMBINATION_PRODUCT

probiotics

Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Fatima Safira Alatas, MD, PhD · Department of Child Health Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
215 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787419 on ClinicalTrials.gov