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IRCT20100524004010N29 IRCT 2020-06-01 Shahid Beheshti University of Medical Sciences the effect of gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome The effect of low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet with and without gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome 2020-07-10 anticipated 50 Complete https://irct.ir/trial/48410 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study، in order to the randomization process، a simple randomization is used by using a table of random numbers.before begining the study،each person is placed in one of the intervention or placebo groups based on a simple random division table.we have considered a two-digit code for the number of sample size numbers, and selected the start point by referring to the table, and based on the adjacent two-digit number, moved in the direction of the row, and we choose the first two-digit number less than 50 as the first smple and we'll continue to do this until the samples reach 50, Blinding description: In this study، patients will receive supplement or placebo with a low FODMAP diet for 6 weeks depending on the group they are in. patients in the supplement group will receive 5gr of gluten and the placebo group will recevie the 5 gr of rice flour which is similar in shape and color to the supplement , once a day and in the form of dissolved in 230 ml of water. group A and group B to the purpose of not informing the researcher of the type of powder used by each group. N/A Irritable bowel syndrome. Intervention 1: Intervention group: Patients in the intervention group will receive 5 gr gluten powder (includes packages of containing 5 gr of measure) once a day , and dissolved in 230 ml water plus a low FODMAP diet for 6 weeks. At first, the subject, objectives and method of the study are explained to patients with irritable bowel syndrome who meet the inclusion criteria, then, if they wish a written consent will be obtained from them.the diet will be explained to the patients, also at the beginning of the study, the height and weight of each patient are measured and BMI will be obtained using the formula ( weight in kg divided by height in meters squared).a valid questionnaire for clincal symptomes and quality of life is completed at the beginning and end of the study. in this study, to checking of the patients' diet, at the end of the second and sixth weeks, 24-hours dietary recall is taken from patients for three days. 24-hours dietary recall questionnaires will be analyzed using N4 nutritinal software.in this stydy, patients will be monitored by call almost once a week due to the follow-up of patients the from diet and if the diet is not followed, they will be excluded from the study. Intervention 2: Control group: Patients in the control group will receive 5 gr rice flur (includes packages of containing 5 gr of measure) once a day , and dissolved in 230 ml water plus a low FODMAP diet for 6 weeks. At first, the subject, objectives and method of the study are explained to patients with irritable bowel syndrome who meet the inclusion criteria, then, if they wish a written consent will be obtained from them.the diet will be explained to the patients, also at the beginning of the study, the height and weight of each patient are measured and BMI will be obtained using the formula ( weight in kg divided by height in meters squared).a valid questionnaire for clincal symptomes and quality of life is completed at the beginning and end of the study. in this study, to checking of the patients' diet, at the end of the second and sixth weeks, 24-hours dietary recall is taken from patients for three days. 24-hours dietary recall questionnaires will be analyzed using N4 nutritinal software.in this stydy, patients will be monitored by call almost once a week due to the follow-up of patients the from diet and if the diet is not followed, they will be excluded from the study. 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 More information is needed
public Azita Hekmatdoost
West Arghavan, Shahrak Gharb
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
No.7, Wast Arghavan .,Farahzadi Blvd.,Qods Town, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2293 0824 a_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years Patients with irritable bowel syndrome, according to a gastroenterologist diagnosed according to ROME IV criteria (having at least one day a week over the past 3 months for at least two of the following: 1- related to Defecation; 2- related to the frequency of defecation, 3- related to changes in stool shape and consistency, and no pathological findings in gastrointestinal Body Mass Index in range (18-25) Lack of any organic intestinal disease ( diagnosed by last 5 years ago colonoscopy) and intestinal infection (diagnosed by stool culture) Lack of medical history of chronic gasrtointestinal and colorectal disease Lack of any major bowel surgery Absence of regular use of laxatives or anti diarreheal drugs No chronic use of corticosteroids and immunosuppressants No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylates No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin and heparin Lack of pregnancy or breastfeeding،athlete or hospitalization Absence of severe mental or behavioral disorder Absence of nicotine and its derivatives use in the last 6 months No usage of NSAIDs and aspirin in last week (effect on gut permeability) 18 years 65 years Both consumption of artificial sweeteners(effet on intestinal permeability) 2 days before entering the study not agree to entering the study K58 Irritable bowel syndrome Other Placebo Intervention group: Patients in the intervention group will receive 5 gr gluten powder (includes packages of containing 5 gr of measure) once a day , and dissolved in 230 ml water plus a low FODMAP diet for 6 weeks. At first, the subject, objectives and method of the study are explained to patients with irritable bowel syndrome who meet the inclusion criteria, then, if they wish a written consent will be obtained from them.the diet will be explained to the patients, also at the beginning of the study, the height and weight of each patient are measured and BMI will be obtained using the formula ( weight in kg divided by height in meters squared).a valid questionnaire for clincal symptomes and quality of life is completed at the beginning and end of the study. in this study, to checking of the patients' diet, at the end of the second and sixth weeks, 24-hours dietary recall is taken from patients for three days. 24-hours dietary recall questionnaires will be analyzed using N4 nutritinal software.in this stydy, patients will be monitored by call almost once a week due to the follow-up of patients the from diet and if the diet is not followed, they will be excluded from the study. Control group: Patients in the control group will receive 5 gr rice flur (includes packages of containing 5 gr of measure) once a day , and dissolved in 230 ml water plus a low FODMAP diet for 6 weeks. At first, the subject, objectives and method of the study are explained to patients with irritable bowel syndrome who meet the inclusion criteria, then, if they wish a written consent will be obtained from them.the diet will be explained to the patients, also at the beginning of the study, the height and weight of each patient are measured and BMI will be obtained using the formula ( weight in kg divided by height in meters squared).a valid questionnaire for clincal symptomes and quality of life is completed at the beginning and end of the study. in this study, to checking of the patients' diet, at the end of the second and sixth weeks, 24-hours dietary recall is taken from patients for three days. 24-hours dietary recall questionnaires will be analyzed using N4 nutritinal software.in this stydy, patients will be monitored by call almost once a week due to the follow-up of patients the from diet and if the diet is not followed, they will be excluded from the study. Quality of life. Timepoint: Beginning and end of study. Method of measurement: Irritable Bowel Syndrome Quality of Life Quality of Life Questionnaire. Irritable Bowel Syndrome- Symptom Severity Score. Timepoint: Beginning and end of study. Method of measurement: Questionnaire (IBS_SSS). Abdominal pain intensity. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale. Abdominal pain frequency. Timepoint: Beginning and end of study. Method of measurement: Questionnaire. Abdominal distention. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale. Satisfaction with bowel habits. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale. Interference with community function. Timepoint: Beginning and end of study. Method of measurement: Visual Analogue Scale. Defecation frequency. Timepoint: Beginning and end of study. Method of measurement: Questinnaire. Defecation consistency. Timepoint: Beginning and end of study. Method of measurement: Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-01-05 Ethicts committe of Shahid Beheshti University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafshan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)