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Effect of PRO LDL supplement on hepatic steatosis

Investigating the effect of PRO LDL probiotic supplement on the severity of hepatic steatosis in patients with nonalcoholic fatty liver diease based on ultrasound criteria

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250102064246N1
Enrollment
80
Registered
2025-01-18
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Hepatic steatosis in patients with nonalcoholic fatty liver disease. Nonalcoholic steatohepatitis (NASH)

Interventions

Intervention 1: Intervention group: Both groups will receive necessary recommendations regarding dietary restrictions and increasing physical activity to at least 30 minutes daily. The Pro LDL capsule

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Presence of hepatic steatosis on ultrasound Informed consent of the patient

Exclusion criteria

Exclusion criteria: Alcohol consumption Viral hepatitis Use of certain medications such as amiodarone, anticonvulsants, and chemotherapy drugs Other chronic liver diseases Patient's refusal to start or continue the study

Design outcomes

Primary

MeasureTime frame
Reduction in the severity of liver steatosis. Timepoint: 90 days after intervention. Method of measurement: Ultrasound for determining the severity of liver steatosis (mild, moderate, severe); Fibrosis-4 (FIB-4) Score, which includes 4 tests: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), platelet count, and age.

Secondary

MeasureTime frame
Control of dyslipidemia. Timepoint: 90 days after intervention. Method of measurement: Lipid profile including: LDL, HDL, triglycerides, cholesterol.;Reduction in liver aminotransferase levels (AST-ALT). Timepoint: 90 days after intervention. Method of measurement: Measurement of serum levels of AST and ALT enzymes.;Control of hypertension. Timepoint: 90 days after intervention. Method of measurement: Blood pressure measurement.;Weight loss. Timepoint: 90 days after intervention. Method of measurement: Weighing scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarnaz Kouhsarian

Gorgan University of Medical Sciences

drkouhsarian@gmail.com+98 17 3220 2154

Outcome results

None listed

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