the effect of gluten on clinical outcomes and quality of life in patients with irritable bowel syndrome

Not Applicable

• Conditions: Irritable bowel syndrome.; Irritable bowel syndrome

• Registration Number: IRCT20100524004010N29
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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)

Exclusion Criteria

consumption of artificial sweeteners(effet on intestinal permeability) 2 days before entering the study
not agree to entering the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: Beginning and end of study. Method of measurement: Irritable Bowel Syndrome Quality of Life Quality of Life Questionnaire.

Secondary Outcome Measures

Name	Time	Method
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.