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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07800650
Acronym
LF-GFD
Enrollment
70
Registered
2026-09-02
Start date
2025-12-24
Completion date
2026-07-25
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, low-FODMAP diet, gluten-free diet

Brief summary

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).

Detailed description

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.

Interventions

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.

OTHERGluten-Free Diet

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.

Sponsors

Ertuğrul Çoruh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants were assigned to one of two parallel dietary intervention groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Total GSRS ScoreBaseline and 4 weeksChange 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

MeasureTime frameDescription
Change in GSRS Constipation Subscale ScoreBaseline and 4 weeksChange 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.
Change in GSRS Abdominal Pain Subscale ScoreBaseline and 4 weeksChange 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.
Change in GSRS Reflux Subscale ScoreBaseline and 4 weeksChange 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.
Change in GSRS Indigestion Subscale ScoreBaseline and 4 weeksChange 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.
Change in GSRS Diarrhea Subscale ScoreBaseline and 4 weeksChange 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORErtuğrul Çoruh, MD

Yıldızkent Family Health Center, Palandöken District Health Directorate, Erzurum, Turkey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026