]>
IRCT20221215056828N1 IRCT 2023-09-03 Shiraz University of Medical Sciences Investigating the effect of Butyrate on inflammatory genes and apoptosis in Ulcerative colitis Effect of Butyrate on anti inflammatory genes Sirt1 and Pgc1alpha and apoptosis gene Bax and Bcl2 in Ulcerative colitis patients 2023-08-24 anticipated 30 Complete https://irct.ir/trial/72248 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: The use of block randomization method, eligible candidates are randomly divided into two groups through 5 blocks of six numbers, in each block there are three volunteers of the intervention group and three volunteers of the placebo group in different order, Blinding description: By a third party who is not involved in the study and is completely unaware of the details of the study, the supplement and placebo are divided and numbered in containers of the same shape.The statistical consultant determines the random sequence and enters the participants into the study and assigns the participants to the intervention groups. The study participants and the researcher are blinded, and a third person outside the study, who is not aware, specifies the codes a and b. 3 Ulcerative Colitis Inflammation. Intervention 1: Intervention group: Sodium Butyrate 600 mg/day. Intervention 2: Control group: Starch 600 mg/day. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Mohammad Vatanpour
Facility of Nutrition, Razi Blv, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 8099 Amirvatanpour24@gmail.com Shiraz University of Medical Sciences scientific Mohammad Vatanpour
Facility of Nutrition, Razi Blv, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 8099 amirvatanpour24@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Male or female 18 to 60 years old Body mass index between 18.5 and 30 Estimating the severity of the disease based on the Mayo The severity of the disease is mild to moderate Patients with ulcerative colitis diagnosed by colonoscopy Informed consent from the patient Patients who are in the quiescent stage of the disease are included in the study, and patients who are in the acute stage of the disease are excluded. The patient should refrain from any self treatment and use of herbal medicines. 18 years 60 years Both Patients with other gastrointestinal diseases including intestinal obstruction, fistula, celiac disease, cancer and infectious diseases Pregnancy and breastfeeding Use of antibiotic drugs and other probiotic products and vitamin and mineral supplements for the previous 2 months. History of hospitalization in the last 3 months Type 2 diabetes patients Acute stage of the disease Change in the process of drug consumption during the study Intensification of the disease during study The place of implementation of the study is Faqihi Hospital and Motahari Clinic of Shiraz University of Medical Sciences K51 Ulcerative colitis Treatment - Drugs Placebo Intervention group: Sodium Butyrate 600 mg/day Control group: Starch 600 mg/day Changes in gene Sirt1 expression. Timepoint: At the beginning of the study and 3 months later (the end of the study). Method of measurement: Real time PCR. Life quality score. Timepoint: At the beginning of the study and 3 months later (the end of the study). Method of measurement: IBDQ9 questionnaire. Shiraz University of Medical Sciences Approved 2023-07-29 Ethics Committee of Shiraz University of Medical Sciences Facility of Nutrition, Razi Blv, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)