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IRCT20190523043680N1 IRCT 2019-06-15 Tehran University of Medical Sciences Effect of Gluten-free Regimen on Ulcerative Colitis Patients Effect of Gluten-free Regimen on the Quality of Life and Disease Severity of Ulcerative Colitis Patients; A Randomised Controlled Clinical Trial 2019-02-20 anticipated 26 Complete https://irct.ir/trial/39979 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use the blocked randomization method to balance the number of cases in each group of study. To prevent any possible anticipation, we will consider each block with different size. Interventions (regimen with and without gluten) is determined with A or B written on a paper putting in a closed envelope. Hence physicians cannot understand the type of interventions. (Allocation Concealment), Blinding description: The produced bread (with or without gluten) has been sent to patients by The representative of the pharmaceutical company. Accordingly, this is only the representative of the pharmaceutical company that is aware of the true types of intervention which makes our study as a tripe blind one. Nutritionists give consults to the patients through a one-hour session and ask all of them to prevent the use of any regimen containing gluten. Additionally, all patients can use a training pamphlet. The pharmaceutical company produces two types of bread which are similar regarding form, their package, and all other characteristics except for the existence of gluten. Hence, we can have a good option for placebo in our study. One type of produced bread is gluten-free (for the intervention group) and another one has 9 grams of gluten (for the placebo group). N/A Ulcerative Colitis. Intervention 1: Intervention group: The produced bread without gluten is sent to patients in the control group by the representative of the producer company (Sahar bread company). Nutritionists give consults to the patients through a one-hour session and ask all of them to prevent the use of any regimen containing gluten. Additionally, all patients can use a training pamphlet. The company produces two types of bread which are similar regarding form, their package, and all other characteristics except for the existence of gluten. Hence, we can have a good option for placebo in our study. One type of produced bread has gluten used in the control group. Intervention 2: Control group: The produced bread with 9 grams gluten is sent to patients in the intervention group by the representative of the producer company (Sahar bread company). Nutritionists give consults to the patients through a one-hour session and ask all of them to prevent the use of any regimen containing gluten. Additionally, all patients can use a training pamphlet. The company produces two types of bread which are similar regarding form, their package, and all other characteristics except for the existence of gluten. Hence, we can have a good option for placebo in our study. One type of produced bread is gluten-free which used in the intervention group. Yes - There is a plan to make this available What will be shared: Study Protocol together with the Statistical Analysis Map, Informed consent from, Participant Data, and report of the clinical study will be published after the end of the study. All of the items can be available except those which can help to identify patients. When: Data will be available together with the published paper of the study. After this, there will be no limitation for accessing data. To whom: There will be no limitation for accessing our data for anybody. Conditions: Our data can be used for future studies like individual meta-analyses. Data will be available in the published paper of our study. Where to obtain: Data will be available in the published paper of our study. How to obtain: There is no need for any request. Data will be available in the published paper of our study. Comments: -
public Reza Hadi
Department of Gastroenterology and Hepatology, Imam Khomeini Hospital, keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1615 mynameisrezahadi@gmail.om Tehran University of Medical Sciences scientific Reza Hadi
Department of gastroenterology and hepatology-Imam Khomeini Hospital-keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1615 mynameisrezahadi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients with at least 18 year-old of age who suffers from mild or moderate ulcerative colitis 18 years no limit Both Patients who suffering from severe type or inactive phase of ulcerative colitis Has a history of surgery due to IBD Using biological medications Those does not complete study protocol K51 Ulcerative colitis Treatment - Other Placebo Intervention group: The produced bread without gluten is sent to patients in the control group by the representative of the producer company (Sahar bread company). Nutritionists give consults to the patients through a one-hour session and ask all of them to prevent the use of any regimen containing gluten. Additionally, all patients can use a training pamphlet. The company produces two types of bread which are similar regarding form, their package, and all other characteristics except for the existence of gluten. Hence, we can have a good option for placebo in our study. One type of produced bread has gluten used in the control group. Control group: The produced bread with 9 grams gluten is sent to patients in the intervention group by the representative of the producer company (Sahar bread company). Nutritionists give consults to the patients through a one-hour session and ask all of them to prevent the use of any regimen containing gluten. Additionally, all patients can use a training pamphlet. The company produces two types of bread which are similar regarding form, their package, and all other characteristics except for the existence of gluten. Hence, we can have a good option for placebo in our study. One type of produced bread is gluten-free which used in the intervention group. Disease Severity. Timepoint: Disease severity is measured in two times . (at starting the study and ending of it which is after 6 weeks of receiving the regimen by patients). Method of measurement: With questionnaire of Simple Clinical Colitis Activity Index (SCCAI). Quality of Life. Timepoint: Quality of life of patients is measured in two times . (at starting the study and ending of it which is after 6 weeks of receiving the regimen by patients). Method of measurement: With Persian version of IBD-Q. Inflammation markers (ESR, CRP and Fecal Calprotectin). Timepoint: Inflammation markers of patients is measured in two times . (at starting the study and ending of it which is after 6 weeks of receiving the regimen by patients). Method of measurement: Routine laboratory methods. Tehran University of Medical Sciences Approved 2019-01-28 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Science, Qods Avenue, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)