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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
dietary treatment (low FODMAP)
dietary treatment (gluten free)
dietary treatment (low FODMAP+gluten free)
dietary treatment (Traditional diet recommendations)
Sponsored by
University of Gaziantep
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring low FODMAP, gluten free diet, irritable bowel syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gaziantep University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1st Group: Traditional diet recommendations

2nd Group: Low FODMAP diet

3rd Group: Gluten-free diet

4th Group: Low-FODMAP gluten-free diet

Arm Description

Traditional diet recommendations will apply for 4 weeks.

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.

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.

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.

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)
this test evaluates the severity of the disease. The overall score of IBS-SSS ranges from 0 to 500. According to this standardized survey, 75-175 points: mild symptom 175--300 points: moderate symptom > 300 points: considered to be severe symptoms.
Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)
this test evaluates the severity of the disease. The overall score of IBS-SSS ranges from 0 to 500. According to this standardized survey, 75-175 points: mild symptom 175--300 points: moderate symptom > 300 points: considered to be severe symptoms.
Irritable Bowel Syndrome Quality of Life Scale (IBS-QQL)
This test determines the quality of life of patients with irritable bowel syndrome. Irritable Bowel Syndrome Quality of Life Scale consists of 34 items and 8 subgroups; Each item in a Likert-type scale has 5 answer options. "1 Nothing", "2 A Little"; "3 Middle"; One of the "4 Too Much" and "5 Too Much" options should be selected. According to these options, the first option is 5; The fifth option is given 1 point and the total score is calculated. Minimum 34 points and maximum 170 points are obtained as total points. An increase in the total score obtained from the scale indicates an increase in the quality of life associated with the disease.
Irritable Bowel Syndrome Quality of Life Scale (IBS-QQL)
This test determines the quality of life of patients with irritable bowel syndrome. Irritable Bowel Syndrome Quality of Life Scale consists of 34 items and 8 subgroups; Each item in a Likert-type scale has 5 answer options. "1 Nothing", "2 A Little"; "3 Middle"; One of the "4 Too Much" and "5 Too Much" options should be selected. According to these options, the first option is 5; The fifth option is given 1 point and the total score is calculated. Minimum 34 points and maximum 170 points are obtained as total points. An increase in the total score obtained from the scale indicates an increase in the quality of life associated with the disease.
Bristol Stool Scale
This test questions the shape and consistency of stool in patients with irritable bowel syndrome. This scale aims to estimate the stool form from 7 different stool shapes. It is understood that there is improvement in the stool form as you approach the number 4 form.
Bristol Stool Scale
This test questions the shape and consistency of stool in patients with irritable bowel syndrome. This scale aims to estimate the stool form from 7 different stool shapes. It is understood that there is improvement in the stool form as you approach the number 4 form.

Secondary Outcome Measures

Food Consumption Frequency Survey including FODMAP Intake
determines the frequency of patients consuming foods containing FODMAPs.
Food Consumption Frequency Survey including FODMAP Intake
determines the frequency of patients consuming foods containing FODMAPs.
Food Consumption Frequency Survey Including Gluten Intake
determines the frequency of patients consuming foods containing gluten.
Food Consumption Frequency Survey Including Gluten Intake
determines the frequency of patients consuming foods containing gluten.

Full Information

First Posted
April 16, 2021
Last Updated
May 17, 2022
Sponsor
University of Gaziantep
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1. Study Identification

Unique Protocol Identification Number
NCT04853381
Brief Title
Comparison of the Effects of Different Nutrition Treatments on Patients With Irritable Bowel Syndrome
Official Title
Comparison of the Effects of Different Medical Nutrition Treatments on Symptoms and Quality of Life of Patients With Irritable Bowel Syndrome and the Acceptability Status of These Dietary Treatments by Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gaziantep

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
low FODMAP, gluten free diet, irritable bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st Group: Traditional diet recommendations
Arm Type
Experimental
Arm Description
Traditional diet recommendations will apply for 4 weeks.
Arm Title
2nd Group: Low FODMAP diet
Arm Type
Experimental
Arm Description
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.
Arm Title
3rd Group: Gluten-free diet
Arm Type
Experimental
Arm Description
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.
Arm Title
4th Group: Low-FODMAP gluten-free diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
dietary treatment (low FODMAP)
Intervention Description
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
Intervention Name(s)
dietary treatment (gluten free)
Intervention Description
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
Intervention Name(s)
dietary treatment (low FODMAP+gluten free)
Intervention Description
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
Intervention Name(s)
dietary treatment (Traditional diet recommendations)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)
Description
this test evaluates the severity of the disease. The overall score of IBS-SSS ranges from 0 to 500. According to this standardized survey, 75-175 points: mild symptom 175--300 points: moderate symptom > 300 points: considered to be severe symptoms.
Time Frame
at baseline
Title
Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)
Description
this test evaluates the severity of the disease. The overall score of IBS-SSS ranges from 0 to 500. According to this standardized survey, 75-175 points: mild symptom 175--300 points: moderate symptom > 300 points: considered to be severe symptoms.
Time Frame
end of the 4th week.
Title
Irritable Bowel Syndrome Quality of Life Scale (IBS-QQL)
Description
This test determines the quality of life of patients with irritable bowel syndrome. Irritable Bowel Syndrome Quality of Life Scale consists of 34 items and 8 subgroups; Each item in a Likert-type scale has 5 answer options. "1 Nothing", "2 A Little"; "3 Middle"; One of the "4 Too Much" and "5 Too Much" options should be selected. According to these options, the first option is 5; The fifth option is given 1 point and the total score is calculated. Minimum 34 points and maximum 170 points are obtained as total points. An increase in the total score obtained from the scale indicates an increase in the quality of life associated with the disease.
Time Frame
at baseline
Title
Irritable Bowel Syndrome Quality of Life Scale (IBS-QQL)
Description
This test determines the quality of life of patients with irritable bowel syndrome. Irritable Bowel Syndrome Quality of Life Scale consists of 34 items and 8 subgroups; Each item in a Likert-type scale has 5 answer options. "1 Nothing", "2 A Little"; "3 Middle"; One of the "4 Too Much" and "5 Too Much" options should be selected. According to these options, the first option is 5; The fifth option is given 1 point and the total score is calculated. Minimum 34 points and maximum 170 points are obtained as total points. An increase in the total score obtained from the scale indicates an increase in the quality of life associated with the disease.
Time Frame
end of the 4th week
Title
Bristol Stool Scale
Description
This test questions the shape and consistency of stool in patients with irritable bowel syndrome. This scale aims to estimate the stool form from 7 different stool shapes. It is understood that there is improvement in the stool form as you approach the number 4 form.
Time Frame
at baseline
Title
Bristol Stool Scale
Description
This test questions the shape and consistency of stool in patients with irritable bowel syndrome. This scale aims to estimate the stool form from 7 different stool shapes. It is understood that there is improvement in the stool form as you approach the number 4 form.
Time Frame
end of the 4th week
Secondary Outcome Measure Information:
Title
Food Consumption Frequency Survey including FODMAP Intake
Description
determines the frequency of patients consuming foods containing FODMAPs.
Time Frame
at baseline
Title
Food Consumption Frequency Survey including FODMAP Intake
Description
determines the frequency of patients consuming foods containing FODMAPs.
Time Frame
end of the 4th week
Title
Food Consumption Frequency Survey Including Gluten Intake
Description
determines the frequency of patients consuming foods containing gluten.
Time Frame
at baseline
Title
Food Consumption Frequency Survey Including Gluten Intake
Description
determines the frequency of patients consuming foods containing gluten.
Time Frame
end of the 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Applying to Gaziantep University Faculty of Medicine Department of Gastroenterology, Between the ages of 19-65, Diagnosed with Irritable Bowel Syndrome by a physician according to Rome IV criteria, 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: Those with gastrointestinal organic diseases (celiac, lactose intolerance, inflammatory bowel diseases), Those diagnosed with clinically important systemic diseases (diabetes, cancer, hypertension, thyroid and other endocrine system diseases), Individuals diagnosed with multiple sclerosis and Parkinson's disease, Individuals with established food allergies, Individuals with major psychiatric diseases, Individuals with eating disorders according to DSM-V criteria, Individuals who have undergone major abdominal surgery, Individuals who were pregnant at the time of the study will not be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S.Mine YURTTAGUL
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Gaziantep University
City
Gaziantep
State/Province
Sehitkamil
ZIP/Postal Code
27060
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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