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IRCT2014010715879N3 IRCT 2015-02-08 Vice chancellor for research, Tabriz university of medical sciences Lactulose effect in non alcoholic fatty liver disease Study of lactulose effects in the treatment of non alcoholic fatty liver disease in comparison with vitamin E: A randomized, clinical trial 2015-02-18 anticipated 40 Complete https://irct.ir/trial/15013 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients will be randomly divided into two groups using the software Randlist 1.2. N/A Non alcoholic fatty liver disease. Intervention 1: Patients in the intervention group receive 20- 30cc lactulose daily for one month. Lactulose syrup (or Laxilose®, 10 g lactulose/15 mL, Alborzdaru) is a synthetic sugar used to treat constipation. In the colon, lactulose is metabolized primarily to lactic acid by bacteria that pull water out from the body and into the colon. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. Lactulose poorly absorbed from the GI tract when given oral. Side effects of drug are diarrhea, gas, nausea, stomach pain or cramps and vomiting. Intervention 2: The intervention 2: Patients in control group receive vitamin E.
public Reza Ghotaslou
Department of microbiology, School of medicine, Tabriz, Iran
Tabriz Iran (Islamic Republic of) +98 41 3336 4661 rzgottaslo@yahoo.com Tabriz university of medical sciences scientific Reza Ghotaslou
Department of microbiology, School of medicine, Daneshgah street, Tabriz, East Azerbaijan, Iran
Tabriz Iran (Islamic Republic of) +98 41 3336 4661 rzgottaslo@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Non alcoholic fatty liver disease, age between 30 and 70 years. Exclusion criteria: Diabetic mellitus, viral hepatitis, congenital hepatitis, drug hepatitis, autoimmune hepatitis, alcohol use, blood triglyceride more than 500mg, inflammatory bowel diseases ( Ulcerative colitis or Crohn's disease), chronic diarrhea, antibiotic use, contraindication of lactolus use, use of medications affecting bowel function, and consent to participate in the study. 30 years 70 years Both K76.0 Non alcoholic fatty liver disease Treatment - Drugs Treatment - Other Patients in the intervention group receive 20- 30cc lactulose daily for one month. Lactulose syrup (or Laxilose®, 10 g lactulose/15 mL, Alborzdaru) is a synthetic sugar used to treat constipation. In the colon, lactulose is metabolized primarily to lactic acid by bacteria that pull water out from the body and into the colon. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. Lactulose poorly absorbed from the GI tract when given oral. Side effects of drug are diarrhea, gas, nausea, stomach pain or cramps and vomiting. The intervention 2: Patients in control group receive vitamin E. Liver size. Timepoint: Baseline and one month after starting the study. Method of measurement: Ultrasound sonography. Intestinal probiotic count. Timepoint: Baseline and one month after starting the study. Method of measurement: Pour plate technique. Drug complications. Timepoint: One month after starting the study. Method of measurement: Ask the patient. Vice chancellor for research, Tabriz university of medical sciences Approved 2014-07-20 Ethics committee of Tabriz university of medical sciences Central building II ,Third floor, Golgasht Street, Tabriz University of Medical Sciences Tabriz Iran (Islamic Republic of)