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The effect of dual-strain probiotics on fatty/steatotic liver disease in children: A randomized controlled trial

The effect of dual-strain probiotics on fatty/steatotic liver disease in children: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251127010
Enrollment
64
Registered
2025-11-27
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Age 9 - 18 years consistent with criteria-defined NAFLD hepatic steatosis which exclude other conditions of hepatic steatosis e.g., genetic disorders (such as fatty acid oxidation defects, mitochondrial disorders, citrin deficiency, Wilson disease, and lysosomal acid lipase deficiency), metabolic disorders (uncontrolled diabetes mellitus, familial combined hyperlipidemia), drugs (amiodarone, corticosteroids, methotrexate, antipsychotic drugs and valproic acid), dietary or toxin causes (severe pr

Interventions

Probiotics will be given to the enrolled children in the probiotics group with one capsule once daily for 3 months. We will collect the potential probiotics-related adverse reactions and other health
Active Comparator Drug,No Intervention No treatment
Probiotics group,Controlled group

Sponsors

Faculty of Medicine Ramathibodi Hospital Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 9 - 18 years consistent with criteria-defined NAFLD hepatic steatosis which exclude other conditions of hepatic steatosis e.g., genetic disorders (such as fatty acid oxidation defects, mitochondrial disorders, citrin deficiency, Wilson disease, and lysosomal acid lipase deficiency), metabolic disorders (uncontrolled diabetes mellitus, familial combined hyperlipidemia), drugs (amiodarone, corticosteroids, methotrexate, antipsychotic drugs and valproic acid), dietary or toxin causes (severe protein-energy malnutrition, alcohol abuse, and parenteral nutrition) and infections or MASLD 2. Able to swallow capsule

Exclusion criteria

Exclusion criteria: 1) Preexisting liver disease or new concomitant liver disease(s) 2) Genetic disease that may predisposed to have steatotic liver diseases such as familial hypocholesterolemia, lipodystrophy, citrin deficiency, Wilson disease and lysosomal acid lipase deficiency 3) Bedridden or bed-bound 4) Antibiotics prophylaxis uses more than 6 months before enrollment 5) Immunosuppressive drug use/Chemotherapy

Design outcomes

Primary

MeasureTime frame
ALT alteration 3 month and 6 month Blood test

Secondary

MeasureTime frame
Anthropometry, inflammatory and metabolic profiles, and liver ultrasonography on fat quantification 3 month and 6 month Blood test, Ultrasonography

Countries

Thailand

Contacts

Public ContactPornthep Tanpowpong

Faculty of Medicine Ramathibodi Hospital

pornthep.tan@mahidol.ac.th022011446

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026