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IRCT20230221057484N1 IRCT 2023-09-05 Tabriz University of Medical Sciences Evaluation of the role of Helicobacter pylori eradication in patients with non-alcoholic fatty liver disease Evaluation of the role of Helicobacter pylori eradication in patients with non-alcoholic fatty liver disease on non-invasive criteria for liver fibrosis including FIB_4, NFS, BARD score 2023-09-21 anticipated 32 Complete https://irct.ir/trial/69208 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Non-alcoholic fatty liver. Intervention group: The People entered according to the entry and exit criteria, the level of body enzymes, the number of platelet, blood sugar were tested and with the help of age, height and weight, liver fibrosis scores (BARD score, NFS score, FIB-4) were determined and then will be treated with a four-drug regimen of Helicobacter pylori with metronidazole(Flagyl®) 400mg three times a day, bismuth(Bismuthan®) 220mg twice a day, amoxicillin(Amorax®) 1g three times a day and pentaprazole(Panzol®) 40mg once a day for 2 weeks and then 6 months After liver fibrosis scores (BARD score, NFS score, FIB-4) using body enzyme level tests, blood platelet count, blood sugar, age, height and weight will be calculated and compared with the previous score.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammad Amin Gorbani Zirian
Next to imam reza hospital,Golgasht sreet
tabriz Iran (Islamic Republic of) 5166614766 +98 41 3553 2032 amin.gorbani77@gmail.com Tabriz University of Medical Sciences scientific Mohammad Amin Gorbani Zirian
Next to imam reza hospital,Golgasht sreet
tabriz Iran (Islamic Republic of) 5166614766 +98 41 3553 2032 amin.gorbani77@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with non-alcoholic fatty liver disease who are more than 18 years old and less than 65 years old Patients whom despite full adherence to diet and lifestyle modification and appropriate physical activity for 6 months,There were no changes in the degree of fatty liver and liver enzymes and non-invasive measures of liver fibrosis 18 years 65 years Both People who have a history of alcohol consumption People who have recently taken antibiotics People who have recently taken proton pump inhibitors K75.8 Other specified inflammatory liver diseases Treatment - Drugs Intervention group: The People entered according to the entry and exit criteria, the level of body enzymes, the number of platelet, blood sugar were tested and with the help of age, height and weight, liver fibrosis scores (BARD score, NFS score, FIB-4) were determined and then will be treated with a four-drug regimen of Helicobacter pylori with metronidazole(Flagyl®) 400mg three times a day, bismuth(Bismuthan®) 220mg twice a day, amoxicillin(Amorax®) 1g three times a day and pentaprazole(Panzol®) 40mg once a day for 2 weeks and then 6 months After liver fibrosis scores (BARD score, NFS score, FIB-4) using body enzyme level tests, blood platelet count, blood sugar, age, height and weight will be calculated and compared with the previous score. BARD score as a non-invasive criteria of liver fibrosis. Timepoint: The exact calculation of BARD score will be done two times (one time at the beginning, before the start of the intervention and the other 6 months after the eradication of Helicobacter pylori). Method of measurement: calculation of score of non-invasive liver fibrosis criteria BARD score. NFS score as a non-invasive criteria of liver fibrosis. Timepoint: The exact calculation of NFS will be done two times (one time at the beginning, before the start of the intervention and the other 6 months after the eradication of Helicobacter pylori). Method of measurement: calculation of score of non-invasive liver fibrosis criteria NFS. FIB_4 score as a non-invasive criteria of liver fibrosis. Timepoint: The exact calculation of FIB_4 will be done two times (one time at the beginning, before the start of the intervention and the other 6 months after the eradication of Helicobacter pylori). Method of measurement: calculation of score of non-invasive liver fibrosis criteria FIB_4. Tabriz University of Medical Sciences Approved 2021-06-28 Ethics committee of tabriz University of Medical Sciences Faculty of Medicine, next to imam reza hospital . golgasht street tabriz East Azarbaijan Iran (Islamic Republic of)