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IRCT20200628047940N3 IRCT 2022-07-18 Shiraz University of Medical Sciences The effect of probiotics consumption on liver function The effect of probiotics consumption on liver function in Primary Sclerosing Cholangitis patients: A double-blinded randomized clinical trial 2022-08-23 anticipated 44 Complete https://irct.ir/trial/63999 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Permutation block design or quadruple blocks will be used. We assign different permutations to numbers 1 to 6 in the following order. 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB Then, using the table of random numbers, we extract the numbers from the table and depending on which one of the numbers 1 to 6 comes, select each of the blocks assigned to these numbers until 11 blocks of quaternary are selected. If the numbers are zero, 7, 8, and 9, we will ignore them and continue this order to provide a complete list for the entire sample size, Blinding description: A gastroenterologist and gastroenterology fellowship select patients eligible to enter the study and willing to participate. The patients will be referred to a trained nurse by introduction letter, who allocate patients to probiotic or placebo groups. The physicians will not be aware of the control and placebo groups. The nurse divide patients based on block randomization, referral time to intervention, and control group. Patients are not informed that they are in the probiotic or placebo group. The patients receive a probiotic (intervention group)or two capsules daily, containing 100 mg of carboxymethylcellulose as a placebo, which in appearance, taste, and packaging box is similar to Femme Lactate. The data analyzer is also unaware of groups. 3 Primary Sclerosing Cholangitis. Intervention 1: Intervention group: probiotic containing Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei Bifidobacterium bruh, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus Famie Lact brand (Zist takhmir Company, Tehran, Iran) is given two capsules daily for three months. Intervention 2: Control group: The capsules containing 100 mg of carboxymethylcellulose are used as a placebo, which in appearance, taste, and packaging box is similar to Femme Lactate, which is prepared by Zisttakhmir Co. Two capsules are given to the control group daily for three months. Patients take their medications routinely during the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Fardad Ejtehadi
Internal medicine group office, Namazi hospital, Namazi Square, Zand St. Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613311 +98 21 3647 4316 edjtehadif@sums.ac.ir Shiraz University of Medical Sciences scientific Fardad Ejtehadi
Internal medicine group office, Namazi hospital, Namazi Square, Zand St. Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613311 +98 21 3647 4316 edjtehadif@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with a definitive diagnosis of primary sclerosing cholangitis(PSC) Patients' informed consent to participate in the study 18 years 75 years Both Neurological disease Chronic alcoholic fatty liver Chronic hepatitis B, C Wilson disease Hemochromatosis disease Secondary sclerosing cholangitis Primary cirrhosis of the bile ducts Benign or malignant tumor of the liver or bile ducts Peritonitis Ascites Variceal bleeding Inflammation of the brain caused by hepatitis in the past 2 months Consumption of probiotics, prebiotics, synbiotics or antibiotics 4 weeks before the start of the study High protein diet Active microbial infection Autoimmune disease or the use of immunosuppressive drugs Probability of liver transplantation in the next year based on secondary sclerosing cholangitis risk score Mayo Alpha antitrypsin deficiency Consumption of ursodeoxycholic acid Consumption of alcohol or drugs Pregnancy and lactation K83.0 Cholangitis Prevention Prevention Intervention group: probiotic containing Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei Bifidobacterium bruh, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus plantarum, Bifidobacterium bifidum and Streptococcus thermophilus Famie Lact brand (Zist takhmir Company, Tehran, Iran) is given two capsules daily for three months Control group: The capsules containing 100 mg of carboxymethylcellulose are used as a placebo, which in appearance, taste, and packaging box is similar to Femme Lactate, which is prepared by Zisttakhmir Co. Two capsules are given to the control group daily for three months. Patients take their medications routinely during the study. Alkaline phosphatase changes. Timepoint: Before the start of study and one month after the end of taking probiotics and placebo. Method of measurement: Alkaline phosphatase test. Total bilirubin changes. Timepoint: Before the start of the study and one month after the end of taking probiotics and placebo. Method of measurement: Total bilirubin test. Primary sclerosing cholangitis risk score changes, based on Mayo clinic. Timepoint: Before the start of the study and one month after the end of taking probiotics and placebo. Method of measurement: Primary sclerosing cholangitis risk score changes, based on Mayo clinic: A decision-making model for primary sclerosing cholangitis based on five variables: 1-Age in years 2-Total bilirubin in mg/dL 3-Serum albumin in g/dL 4-AST in IU/L 5-Variceal bleeding. Shiraz University of Medical Sciences Approved 2022-05-01 Ethics Committee of Medical School, Shiraz University of Medical Sciences Ethics Commitee, Shiraz School of Medicine, Imam Hossein Square Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)