Irritable Bowel SyndromeNCT04853381
Comparison of the Effects of Different Nutrition Treatments on Patients With Irritable Bowel Syndrome
A study testing dietary treatment (low FODMAP), dietary treatment (gluten free) and dietary treatment (low FODMAP+gluten free) in people with Irritable Bowel Syndrome, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- dietary treatment (low FODMAP), dietary treatment (gluten free) and dietary treatment (low FODMAP+gluten free)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2021to 12 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Sehitkamil, 27060
About this study
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
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.
Read the 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
- Being tested
- dietary treatment (low FODMAP), dietary treatment (gluten free), dietary treatment (low FODMAP+gluten free), dietary treatment (Traditional diet recommendations)
- Keywords
- low FODMAP, gluten free diet, irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary treatment (low FODMAP)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.
dietary treatment (gluten free)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.
dietary treatment (low FODMAP+gluten free)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.
dietary treatment (Traditional diet recommendations)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.
| Study group | Role | What they receive |
|---|---|---|
| 1st Group: Traditional diet recommendations | Experimental | Traditional diet recommendations will apply for 4 weeks. Receives: Other: dietary treatment (Traditional diet recommendations) |
| 2nd Group: Low FODMAP diet | Experimental | 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. Receives: Other: dietary treatment (low FODMAP) |
| 3rd Group: Gluten-free diet | Experimental | 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. Receives: Other: dietary treatment (gluten free) |
| 4th Group: Low-FODMAP gluten-free diet | Experimental | 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. Receives: Other: dietary treatment (low FODMAP+gluten free) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline
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.
Measured: end of the 4th week.
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.
Measured: at baseline
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.
Measured: end of the 4th week
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.
Measured: at baseline
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.
Measured: end of the 4th week
Secondary outcomes (4)
Food Consumption Frequency Survey including FODMAP Intake
determines the frequency of patients consuming foods containing FODMAPs.
Measured: at baseline
Food Consumption Frequency Survey including FODMAP Intake
determines the frequency of patients consuming foods containing FODMAPs.
Measured: end of the 4th week
Food Consumption Frequency Survey Including Gluten Intake
determines the frequency of patients consuming foods containing gluten.
Measured: at baseline
Food Consumption Frequency Survey Including Gluten Intake
determines the frequency of patients consuming foods containing gluten.
Measured: end of the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start21 Apr 2021
- Primary completion22 Dec 2021
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezihe Otay Lule, University of Gaziantep
- Investigators
- S.Mine YURTTAGUL, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853381
- Sponsor's protocol ID
- nolule
- Status last verified
- May 2022
- First submitted
- 16 Apr 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Otay Lule N, Yurttagul M, Yildirim AE, Lule KO. Comparative Effects of Four Dietary Approaches on Symptom Severity and Quality of Life in Irritable Bowel Syndrome: A Randomized Controlled Trial. Dig Dis Sci. 2026 Jul 20. doi: 10.1007/s10620-026-10126-1. Online ahead of print.
PubMed 42474623
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853381
- Acronym / sponsor ID
- nolule
- Conditions
- Irritable Bowel Syndrome
- Keywords
- low FODMAP, gluten free diet, irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1st Group: Traditional diet recommendations | Experimental | Other: dietary treatment (Traditional diet recommendations)Traditional diet recommendations will apply for 4 weeks. |
| 2nd Group: Low FODMAP diet | Experimental | Other: dietary treatment (low FODMAP)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. |
| 3rd Group: Gluten-free diet | Experimental | Other: dietary treatment (gluten free)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. |
| 4th Group: Low-FODMAP gluten-free diet | Experimental | Other: dietary treatment (low FODMAP+gluten free)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | 2nd Group: Low FODMAP diet |
| 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. | Other | 3rd Group: Gluten-free diet |
| 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. | Other | 4th Group: Low-FODMAP gluten-free diet |
| 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. | Other | 1st Group: Traditional diet recommendations |
Primary outcome
Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)
Time frame: at baseline
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)
Time frame: end of the 4th week.
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)
Time frame: at baseline
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)
Time frame: end of the 4th week
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
Time frame: at baseline
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
Time frame: end of the 4th week
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.
4 secondary outcomes
Food Consumption Frequency Survey including FODMAP Intake
Time frame: at baseline
Food Consumption Frequency Survey including FODMAP Intake
Time frame: end of the 4th week
Food Consumption Frequency Survey Including Gluten Intake
Time frame: at baseline
Food Consumption Frequency Survey Including Gluten Intake
Time frame: end of the 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 42474623Otay Lule N, Yurttagul M, Yildirim AE, Lule KO. Comparative Effects of Four Dietary Approaches on Symptom Severity and Quality of Life in Irritable Bowel Syndrome: A Randomized Controlled Trial. Dig Dis Sci. 2026 Jul 20. doi: 10.1007/s10620-026-10126-1. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S.Mine YURTTAGUL study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary treatment (low FODMAP), dietary treatment (gluten free) and dietary treatment (low FODMAP+gluten free) in people with Irritable Bowel Syndrome, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS) (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.