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Completed

NCT Number: NCT07800650

Low-FODMAP vs Gluten-Free Diet in Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and irregular bowel habits. Dietary interventions, particularly low-FODMAP and gluten-free diets, have gained increasing interest in IBS management. However, comparative data on these two approaches remain limited across different populations, including the Turkish population. This study was designed to compare the effectiveness of a 4-week low-FODMAP diet versus a gluten-free diet on gastrointestinal symptoms in Turkish patients with IBS.

A total of 70 patients diagnosed with IBS according to Rome IV criteria were enrolled in this prospective, controlled, parallel-group clinical trial. Patients were sequentially assigned to either the low-FODMAP group (n=35) or the gluten-free diet group (n=35). Both dietary interventions were implemented over 4 weeks under the guidance of an experienced dietitian, with weekly telephone follow-ups to monitor dietary compliance. Gastrointestinal symptoms were evaluated at baseline and at the end of the intervention using the Gastrointestinal Symptom Rating Scale (GSRS).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yıldızkent Family Health Center

Erzurum, 25080, Turkey (Türkiye)

About this study

Study Design This study was designed as a prospective, parallel-group, controlled clinical intervention trial. Patients presenting at the outpatient clinic were sequentially assigned to either a low-FODMAP or a gluten-free diet group.

Participants Inclusion criteria were: diagnosis of Irritable Bowel Syndrome according to Rome IV criteria, age between 18 and 65 years, literacy, and provision of written informed consent.

Exclusion criteria

included: psychiatric or neurological conditions affecting cooperation (e.g., dementia, psychosis); chronic conditions (celiac disease, inflammatory bowel disease, diabetes, chronic kidney failure, liver failure, malignancy); regular use of medication for IBS symptoms (antispasmodics, loperamide, laxatives, antidepressants); eating disorders (anorexia nervosa, bulimia nervosa); malabsorption syndromes preventing dietary adherence; and pregnancy or breastfeeding.

Data Collection Tools Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS). This scale comprises 15 items, each scored from 1 (no discomfort) to 7 (very severe discomfort), and includes five sub-dimensions: reflux (items 2 and 3), abdominal pain (items 1, 4, and 5), indigestion (items 6-9), diarrhea (items 11, 12, and 14), and constipation (items 10, 13, and 15). The Turkish validity and reliability study of the GSRS was conducted by Turan et al. (2017), with test-retest reliability coefficients ranging from 0.39 to 0.87 and a Cronbach's alpha coefficient of 0.82. The scale was self-administered at baseline (pre-test) and upon completion of the 4-week dietary intervention (post-test).

Dietary Interventions Patients were allocated to either the low-FODMAP or gluten-free diet group in order of presentation. All participants received individual dietary counseling from an experienced dietitian who was one of the study researchers.

Patients in the low-FODMAP diet group were advised to restrict foods high in FODMAPs (onions, garlic, pulses, certain fruits and vegetables, wheat products) and to choose low-FODMAP alternatives (rice, oats, potatoes, carrots, eggplant, bananas, etc.).

Patients in the gluten-free diet group were provided with a detailed diet plan excluding gluten-containing grains (wheat, barley, rye) and their derivatives (bread, pasta, pastries, biscuits), along with a list of naturally gluten-free foods (rice, corn, potatoes, meat, vegetables, fruits).

Both dietary interventions were applied over a 4-week period. Weekly telephone follow-ups were conducted by the research dietitian to assess adherence and address any issues.

Ethics Committee Approval Ethical approval was obtained from the Clinical Research Ethics Committee of Atatürk University, Erzurum (Meeting No. 9, Decision No. 50) on 31 October 2025. All participants received detailed information about the study procedures and provided written informed consent. Data confidentiality and integrity were maintained throughout the research, and the study was conducted in accordance with the revised principles of the Declaration of Helsinki.

Statistical Analysis Statistical analyses were performed using IBM SPSS Statistics 23. Normality was assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests, Q-Q plots, and skewness/kurtosis measures, indicating non-normal distribution. Descriptive statistics were presented as frequency (n) and percentage (%) for categorical variables, and as mean ± standard deviation (SD) for continuous variables. The Pearson chi-square test was used for categorical comparisons, with Fisher's Exact Test applied when expected frequencies were below 5. Within-group comparisons (pre- vs post-diet) were performed using the Wilcoxon signed-rank test, while between-group comparisons of change scores were performed using the Mann-Whitney U test. A p-value of <0.05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Irritable Bowel Syndrome (IBS) according to the Rome IV diagnostic criteria
  • Aged between 18 and 65 years
  • Literate
  • Signed the informed consent form

Exclusion criteria

  • Psychiatric or neurological condition affecting cooperation (dementia, psychosis, etc.)
  • Chronic condition (celiac disease, inflammatory bowel disease, diabetes, chronic kidney failure, liver failure, malignancy)
  • Regular use of medication for IBS symptoms (antispasmodics, loperamide, laxatives, antidepressants, etc.)
  • Eating disorder (anorexia nervosa, bulimia nervosa, etc.)
  • Malabsorption syndrome preventing adherence to the diet
  • Pregnancy or breastfeeding

Treatment and study plan

Low-FODMAP diet

Other

Participants were instructed to limit foods high in FODMAPs (onions, garlic, pulses, certain fruits and vegetables, wheat products) and to consume low-FODMAP alternatives (rice, oats, potatoes, carrots, bananas). The diet was applied for 4 weeks.

Gluten-free diet

Other

Participants were instructed to exclude gluten-containing grains (wheat, barley, rye) and their derivatives (bread, pasta, pastries), and to consume naturally gluten-free foods (rice, corn, potatoes, meat, vegetables, fruits). The diet was applied for 4 weeks.

Primary outcomes

  1. Change in Total GSRS Score

    Time frame: Baseline and 4 weeks

    Change in the total Gastrointestinal Symptom Rating Scale (GSRS) score from baseline to 4 weeks. The GSRS is a 15-item scale with total scores ranging from 15 to 105. Higher scores indicate more severe gastrointestinal symptoms.

Secondary outcomes

  1. Change in GSRS Diarrhea Subscale Score

    Time frame: Baseline and 4 weeks

    Change in the diarrhea subscale score of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline to 4 weeks. The subscale includes items 11, 12, and 14. Scores range from 1 to 7, with higher scores indicating more severe symptoms.

  2. Change in GSRS Indigestion Subscale Score

    Time frame: Baseline and 4 weeks

    Change in the indigestion subscale score of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline to 4 weeks. The subscale includes items 6, 7, 8, and 9. Scores range from 1 to 7, with higher scores indicating more severe symptoms.

  3. Change in GSRS Constipation Subscale Score

    Time frame: Baseline and 4 weeks

    Change in the constipation subscale score of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline to 4 weeks. The subscale includes items 10, 13, and 15. Scores range from 1 to 7, with higher scores indicating more severe symptoms.

  4. Change in GSRS Abdominal Pain Subscale Score

    Time frame: Baseline and 4 weeks

    Change in the abdominal pain subscale score of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline to 4 weeks. The subscale includes items 1, 4, and 5. Scores range from 1 to 7, with higher scores indicating more severe symptoms.

  5. Change in GSRS Reflux Subscale Score

    Time frame: Baseline and 4 weeks

    Change in the reflux subscale score of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline to 4 weeks. The subscale includes items 2 and 3. Scores range from 1 to 7, with higher scores indicating more severe symptoms.

Sponsors and collaborators

Lead sponsor

Ertuğrul Çoruh

Other

Registry information

Official study title

Comparison of the Efficacy of Low-FODMAP and Gluten-Free Diets in the Dietary Management of Irritable Bowel Syndrome in a Turkish Population: A Prospective, Controlled, Parallel-Group Clinical Trial

Acronym: LF-GFD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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