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IRCT20100524004010N26 IRCT 2018-10-20 Shahid Beheshti University of Medical Sciences Effect of gluten free diet in treatment of IBS The efficacy of gluten free diet on clinical symptoms and signs, quality of life, and inflammatory factors in patients with irritable bowel syndrome under low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet 2017-09-22 anticipated 40 Complete https://irct.ir/trial/34159 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method use in this study to create a randomization process is simple randomization, so we utilize random number table. Beginning of the study, each person is randomly assigned to one of the three study groups according to the randomized distribution table. N/A Irritable Bowel Syndrom. Intervention 1: Intervention group: 1) Group I: will receive food products with 8g/day gluten for first 2 weeks, 16g/day gluten for second 2 weeks, following 32g/day gluten for third 2 weeks. Intervention 2: Intervention group: 2) Group II: will continue low FODMAP+ strict (Gluten free) diet for 6 weeks. Intervention 3: Control group: will receive free diet for 6 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because the participant’s informations should remain confidental.
public Dr Azita Hekmatdoost
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2237 6480 A_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences scientific Azita Hekmatdoost
Hafezi Ave, Shahid Farahzadi Blvd, Shahrak Qarb
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2237 6480 A_hekmat2000@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 18-65 years Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria (1.Improvement with defecation 2.Onset associated with a change in stool frequency 3.Onset associated with a change in stool form (appearance) At least three days a month, three months a year and no pathological findings in the clinical investigating) lack of any organic intestinal disease(diagnosed by last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture). No medical history of chronic gastrointestinal and colorectal disease Absence of any major bowel surgery Absence of regular use of laxatives or antidiarrheal drugs No chronic use of antibiotics, corticosteroids and immunosuppressants No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylate,… No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin, heparin,… No history of breast cancer in patient or in first-degree relatives of a person Absence of severe mental or behavioral disorder Absence of nicotine and its derivatives use in last 6 months No usage of NSAIDs and aspirin in last week(influence on gut permeability) 18 years 65 years Both k55-k64 Other diseases of intestines Treatment - Other Treatment - Other N/A Intervention group: 1) Group I: will receive food products with 8g/day gluten for first 2 weeks, 16g/day gluten for second 2 weeks, following 32g/day gluten for third 2 weeks. Intervention group: 2) Group II: will continue low FODMAP+ strict (Gluten free) diet for 6 weeks. Control group: will receive free diet for 6 weeks Age. Timepoint: Beginning of study. Method of measurement: Question. Gender. Timepoint: Beginning of study. Method of measurement: Observation. Weight. Timepoint: Beginning and end of study. Method of measurement: Balance. Height. Timepoint: Beginning and end of study. Method of measurement: Meter. BMI. Timepoint: Beginning and end of study. Method of measurement: Calculation. Smoking. Timepoint: Beginning of study. Method of measurement: Question. Type of diet. Timepoint: Beginning and end of study. Method of measurement: Data collection form. Total Calorie Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Carbohydrate Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Protein Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Fat Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total Fiber Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total MUFA Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total PUFA Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. Total SFA Intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare. IL-6. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. INF-ɣ. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. Shahid Beheshti University of Medical Sciences Approved 2017-10-15 Ethics Committee Of Shahid Beheshti University Of Medical Sciences Velenjak St. , Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)