Irritable Bowel Syndrome
Conditions
Keywords
Anxiety, Irritable Bowel Syndrome, Diet, FODMAPs, Lactose-free and gluten-free diet
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALLow-FODMAP Diet
Participants followed a low-FODMAP diet for 4 weeks under the supervision of a dietitian.
BEHAVIORALLactose- and Gluten-Free Diet
Participants followed a lactose- and gluten-free diet for 4 weeks under the supervision of a dietitian.
Sponsors
Antalya Bilim University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomized to two crossover sequences. Each participant received both dietary interventions (low-FODMAP diet and lactose- and gluten-free diet) for 4 weeks each, separated by a 1-week washout period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-64 years. * Diagnosis of Irritable Bowel Syndrome according to the Rome III criteria. * Ability and willingness to comply with the dietary intervention. * Written informed consent provided.
Exclusion criteria
* Pregnancy or lactation. * Diabetes mellitus. * Organic gastrointestinal disease. * Current follow-up for cardiologic, neurologic, oncologic, or psychiatric disorders. * Following a therapeutic diet within 1 month before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) | Baseline, Week 4, and Week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) score | Baseline, Week 4, and Week 9 | 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. |
| Change in Hospital Anxiety and Depression Scale (HADS) score | Baseline, Week 4, and Week 9 | 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. |
| Change in body weight | Baseline, Week 4, and Week 9 | Change in body weight measured in kilograms. |
| Change in body mass index | Baseline, Week 4, and Week 9 | Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORHatice Kübra Aras
Antalya Bilim University
Outcome results
None listed