Comparison of the Effects of Different Nutrition Treatments on Patients With Irritable Bowel Syndrome

NCT ID: NCT04853381

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2022-01-12

Brief 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.

Detailed 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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1st Group: Traditional diet recommendations

Traditional diet recommendations will apply for 4 weeks.

Group Type: EXPERIMENTAL

dietary treatment (Traditional diet recommendations)

Intervention Type: OTHER

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.

2nd Group: Low FODMAP diet

Low FODMAP diet recommendations will apply for 4 weeks. 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.

Group Type: EXPERIMENTAL

dietary treatment (low FODMAP)

Intervention Type: OTHER

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.

3rd Group: Gluten-free diet

Gluten-free diet recommendations will apply for 4 weeks. 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.

Group Type: EXPERIMENTAL

dietary treatment (gluten free)

Intervention Type: OTHER

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.

4th Group: Low-FODMAP gluten-free diet

Low-FODMAP gluten-free diet recommendations will apply for 4 weeks. 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.

Group Type: EXPERIMENTAL

dietary treatment (low FODMAP+gluten free)

Intervention Type: OTHER

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.

Interventions

dietary treatment (low FODMAP)

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.

Intervention Type: OTHER

dietary treatment (gluten free)

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.

Intervention Type: OTHER

dietary treatment (low FODMAP+gluten free)

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.

Intervention Type: OTHER

dietary treatment (Traditional diet recommendations)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Applying to Gaziantep University Faculty of Medicine Department of Gastroenterology,

2. Between the ages of 19-65,

3. Diagnosed with Irritable Bowel Syndrome by a physician according to Rome IV criteria,

4. Patients who voluntarily accept to participate in the study will be included in the study after explaining the purpose and method of the study.

Exclusion Criteria

1. Those with gastrointestinal organic diseases (celiac, lactose intolerance, inflammatory bowel diseases),

2. Those diagnosed with clinically important systemic diseases (diabetes, cancer, hypertension, thyroid and other endocrine system diseases),

3. Individuals diagnosed with multiple sclerosis and Parkinson's disease,

4. Individuals with established food allergies,

5. Individuals with major psychiatric diseases,

6. Individuals with eating disorders according to DSM-V criteria,

7. Individuals who have undergone major abdominal surgery,

8. Individuals who were pregnant at the time of the study will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gaziantep

OTHER

Sponsor Role: lead

Responsible Party

Nezihe Otay Lule

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

S.Mine YURTTAGUL

Role: STUDY_DIRECTOR

Hasan Kalyoncu University

Locations

Gaziantep University

Gaziantep, Sehitkamil, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

nolule

Identifier Type: -

Identifier Source: org_study_id