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IRCT20260524069511N1 IRCT 2026-08-30 Ahvaz University of Medical Sciences Effect of Rifaximin in Patients with Metabolic Dysfunction-Associated Fatty Liver Disease Effect of Rifaximin on Changes in Fibrosis-4 Index and Liver Stiffness Measurement by Transient Elastography in Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Clinical Trial 2026-07-23 anticipated 60 Recruiting https://irct.ir/trial/90504 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized to either the rifaximin or placebo group using block randomization with a block size of 4 and a 1:1 allocation ratio. The randomization sequence will be generated using Sealed Envelope software and maintained by an independent statistician who is not involved in the conduct of the study. Allocation codes will be provided to the research pharmacy. The research pharmacy will prepare rifaximin and placebo packages labeled with unique identification numbers according to the randomization list. Upon enrollment, each participant will be assigned the next sequentially numbered study package based on the predetermined allocation sequence. This procedure ensures that the randomization sequence remains concealed from the investigators until the participant has been assigned to a study group, Blinding description: This study will be conducted as a double-blind trial. In this design, participants, treating physicians, clinical staff, outcome assessors, transient elastography operators, and data analysts will remain unaware of treatment allocation. The rifaximin and placebo formulations will be identical in appearance, size, color, packaging, and labeling to ensure that treatment groups cannot be distinguished. Drug preparation and coding will be performed by the research pharmacy. Only the research pharmacy and an independent statistician will have access to the randomization codes. Throughout the study, neither participants nor members of the research team will have access to the allocation sequence, and blinding will be maintained until the completion of data analysis. 2 Metabolic Dysfunction-Associated Steatotic Liver Disease. Intervention 1: Intervention group: Patients with metabolic dysfunction-associated steatotic liver disease (MASLD), after randomization, will receive Rifaximin 550 mg (manufactured by Tehran Darou Pharmaceutical Co., Iran) orally twice daily at 12-hour intervals for 6 months. The medication will be provided as oral capsules in identical, coded packaging by the research pharmacy. Throughout the study, patients will continue to receive standard treatment and routine care for MASLD according to the judgment of their treating physician. Intervention 2: Control group: Control group: Patients with MASLD who are randomized to the control group will receive a placebo identical to rifaximin (manufactured by Tehran Darou Pharmaceutical Co., Iran) every 12 hours (twice daily) for 6 months. The placebo will be identical to the active drug in appearance, weight, size, and packaging. Patients in this group will also receive standard treatment for MASLD according to the diagnosis and treating physician's judgment. No - There is not a plan to make this available Justification or reason for not sharing IPD is No additional information is available.
public Pezhman Alavinejad
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
Ahvaz Iran (Islamic Republic of) ۶۱۹۳۶۷۳۱۱۱ +98 61 3332 5431 alavinejad-p@ajums.ac.ir Ahvaz University of Medical Sciences scientific Pezhman Alavinejad
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) ۶۱۹۳۶۷۳۱۱۱ +98 61 3332 5431 alavinejad-p@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Signed informed consent form. Diagnosis of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) based on medical history and valid diagnostic documentation, including imaging findings, previous liver biopsy reports, or other medical records confirming the diagnosis. Stable clinical condition, including Child-Pugh class A or B with a score of 8 or less and without failure of vital organs. Presence of Fibrosis-4 Index (FIB-4) or Liver Stiffness Measurement (LSM) within a range indicative of monitorable liver fibrosis. No systemic antibiotic or probiotic use within 4 weeks prior to screening. Age between 18 and 75 years old. 18 years 75 years Both Clinically active hepatic encephalopathy, grade II or higher, or a history of hospitalization due to hepatic encephalopathy within the past three months. Active hepatocellular carcinoma (HCC) or other active malignancies. Current use of rifaximin or medications with clinically significant interactions with rifaximin.. A known history of hypersensitivity or allergy to rifaximin or any of its components. Severe renal impairment, including an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m² or requiring dialysis. Pregnancy or breastfeeding: Women of childbearing potential must have a negative pregnancy test and agree to use a reliable method of contraception throughout the study. Concurrent participation in another interventional study or use of any medication or treatment that could significantly affect the study outcomes, such as statins or similar therapies, depending on the study protocol. Presence of serious comorbid conditions that would make participation in the study impossible or unsafe, such as unstable cardiac disease, active systemic infection, or other severe clinical conditions. Inability to comply with the study instructions or inability to attend the study visits and follow-up assessments K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients with metabolic dysfunction-associated steatotic liver disease (MASLD), after randomization, will receive Rifaximin 550 mg (manufactured by Tehran Darou Pharmaceutical Co., Iran) orally twice daily at 12-hour intervals for 6 months. The medication will be provided as oral capsules in identical, coded packaging by the research pharmacy. Throughout the study, patients will continue to receive standard treatment and routine care for MASLD according to the judgment of their treating physician. Control group: Control group: Patients with MASLD who are randomized to the control group will receive a placebo identical to rifaximin (manufactured by Tehran Darou Pharmaceutical Co., Iran) every 12 hours (twice daily) for 6 months. The placebo will be identical to the active drug in appearance, weight, size, and packaging. Patients in this group will also receive standard treatment for MASLD according to the diagnosis and treating physician's judgment. Fibrosis-4 index (FIB-4). Timepoint: Before the start of the intervention (Baseline) and 6 months after the start of the intervention. Method of measurement: The FIB-4 index will be calculated using the standard formula: FIB-4 = (Age × AST) / (Platelet count × √ALT). AST, ALT, and platelet count values will be obtained from blood tests performed in the central study laboratory. Measurement tools: Complete Blood Count (CBC) and Liver Function Tests (LFTs). Liver stiffness measurement (LSM). Timepoint: Before the start of the intervention (Baseline) and 6 months after the start of the intervention. Method of measurement: Liver stiffness measurement (LSM) will be assessed using FibroScan (Transient Elastography) and reported in kilopascals (kPa). Measurement tool: FibroScan device.Time point(s) of assessment:At baseline and 6 months after initiation of the intervention. Alanine aminotransferase. Timepoint: Before the start of the intervention (baseline), and at 3 and 6 months after the start of the intervention. Method of measurement: will be measured using an automated laboratory biochemistry analyzer. CRP. Timepoint: Before the start of the intervention (baseline), and at 3 and 6 months after the start of the intervention. Method of measurement: will be measured using an automated laboratory biochemistry analyzer. AST level. Timepoint: Before the start of the intervention (baseline), and at 3 and 6 months after the start of the intervention. Method of measurement: Measurement of serum aspartate aminotransferase (AST) level using standard laboratory biochemical assays, expressed in U/L. Albumin level. Timepoint: Before the start of the intervention (baseline), and at 3 and 6 months after the start of the intervention. Method of measurement: Measurement of serum albumin level using a standard laboratory biochemical assay, expressed in g/dL. Bilirubin level. Timepoint: Before the start of the intervention (baseline), and at 3 and 6 months after the start of the intervention. Method of measurement: Measurement of serum bilirubin level using a standard laboratory biochemical assay, expressed in mg/dL. Ahvaz University of Medical Sciences Approved 2026-05-09 Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Khuzestan, Iran Ahvaz Khouzestan Iran (Islamic Republic of)