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Clinical Trial Summary

Irritable Bowel Syndrome (IBS) is a disease associated with changes in bowel habits characterized by unexplained abdominal discomfort or pain. Common symptoms of the disease include gas, bloating, diarrhea, constipation, and common gastrointestinal problems associated with psychosocial problems. IBS makes it difficult for patients to attend school and work, reduce productivity, increase healthcare costs and negatively affect quality of life. Although IBS is not a life-threatening disease, it is a condition that must be tackled throughout life. The disease is clinically managed through dietary interventions and appropriate lifestyle changes, and pharmacological symptom-targeted or psychological treatments. The aim of this study is to determine the effects of different dietary treatment methods on patients 'severity symptom score and quality of life, and the patients' compliance with different dietary treatments.


Clinical Trial Description

Patients between the ages of 19-65 who applied to Gaziantep University Faculty of Medicine, Department of Gastroenterology and diagnosed with Irritable Bowel Syndrome by the physician according to the Rome IV criteria will be included in the study. The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period. Written consent will be obtained from individuals who agree to participate in the study. The minimum number of individuals in each group was determined to be 13 when the power was calculated as 80 at a 95% confidence interval. Individuals who accepted to participate in the study will be randomized into 4 different groups by minimization method according to age, gender, irritable bowel syndrome subtypes (diarrhea, constipation, mixed / undefined) and initial irritable bowel syndrome severity scores (mild, moderate, severe):. 1st Group: Traditional diet recommendations, 2nd Group: Low FODMAP diet, 3rd Group: Gluten-free diet, 4th Group: Low-FODMAP gluten-free diet. When individuals are first enrolled in the study, they will be trained by the dietician for one hour before the medical nutrition treatment they will apply for 4 weeks. "Irritable Bowel Syndrome Severity Scoring Scale", "Bristol Stool Scale", "Irritable Bowel Syndrome Quality of Life Scale", "Food Consumption Frequency Survey including FODMAP Intake" and "Food Consumption Frequency Survey Including Gluten Intake" will be applied to individuals at the beginning of the study and at the end of the 4th week. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04853381
Study type Interventional
Source University of Gaziantep
Contact Nezihe Otay Lule
Phone 05062881923
Email [email protected]
Status Recruiting
Phase N/A
Start date April 21, 2021
Completion date August 30, 2021

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