Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder that substantially affects quality of life. Dietary therapy is considered one of the primary treatment approaches; however, the optimal sequence of dietary interventions remains unclear. This randomized crossover trial was designed to compare the effects of a low-FODMAP diet and a lactose-free, gluten-free diet on gastrointestinal symptoms, psychological status, anthropometric measurements, and biochemical parameters in adults with IBS. Participants were randomly assigned to one of two dietary sequences, with each intervention lasting four weeks and separated by a one-week washout period. Outcomes were assessed using validated symptom and psychological questionnaires together with anthropometric and biochemical measurements before and after each intervention period.
This randomized crossover trial was designed to evaluate the comparative effects of a low-FODMAP diet and a lactose- and gluten-free diet in adults with irritable bowel syndrome (IBS). Participants were randomly assigned to one of two dietary sequences, with each intervention lasting 4 weeks and separated by a 1-week washout period. Gastrointestinal symptoms, psychological outcomes, anthropometric measurements, and biochemical parameters were assessed before and after each intervention period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Participants followed a low-FODMAP diet for 4 weeks under the supervision of a dietitian.
Participants followed a lactose- and gluten-free diet for 4 weeks under the supervision of a dietitian.
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Gastroenterology
Istanbul, Turkey (Türkiye)
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). The IBS Symptom Severity Score assessed the severity of IBS symptoms based on four questions, scoring between 0 and 100 points for each symptom. A total score of 75-174 points indicated mild IBS, 175-299 points indicated moderate IBS, and \>300 points indicated severe IBS.
Time frame: Baseline, Week 4, and Week 9
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Change in gastrointestinal symptom severity assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS assessed gastrointestinal symptoms based on 15 items categorized into five subdimensions: abdominal pain, reflux, diarrhea, indigestion, and constipation. The scale measures symptom severity over the past week, with higher scores indicating more severe symptoms.
Time frame: Baseline, Week 4, and Week 9
Change in Hospital Anxiety and Depression Scale (HADS) score
Change in anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-question scale that identifies anxiety and depression risks. The scale is divided into two subscales, one for anxiety and one for depression, with scores ranging from 0 to 21. Scores between 0-7 are considered normal, 8-10 borderline, and ≥11 indicates anxiety and/or depression.
Time frame: Baseline, Week 4, and Week 9
Change in body weight
Change in body weight measured in kilograms.
Time frame: Baseline, Week 4, and Week 9
Change in body mass index
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared.
Time frame: Baseline, Week 4, and Week 9
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