Low-FODMAP vs Lactose-Gluten-Free Diet in Patients With Irritable Bowel Syndrome
21 juli 2026 uppdaterad av: Antalya Bilim University
Comparative Effects of Low-FODMAP and Lactose-Gluten-Free Diets on Gastrointestinal Symptoms and Mental Health in Irritable Bowel Syndrome: A Randomized Crossover Trial
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye)
- Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Gastroenterology
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Low-FODMAP → Lactose- and Gluten-Free Diet
Participants received the low-FODMAP diet for 4 weeks, followed by a 1-week washout period and then the lactose- and gluten-free diet for 4 weeks.
|
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.
|
|
Experimentell: Lactose- and Gluten-Free Diet → Low-FODMAP
Participants received the lactose- and gluten-free diet for 4 weeks, followed by a 1-week washout period and then the low-FODMAP diet for 4 weeks.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Tidsram: 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.
|
Baseline, Week 4, and Week 9
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Tidsram: 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.
|
Baseline, Week 4, and Week 9
|
|
Change in Hospital Anxiety and Depression Scale (HADS) score
Tidsram: 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.
|
Baseline, Week 4, and Week 9
|
|
Change in body weight
Tidsram: Baseline, Week 4, and Week 9
|
Change in body weight measured in kilograms.
|
Baseline, Week 4, and Week 9
|
|
Change in body mass index
Tidsram: Baseline, Week 4, and Week 9
|
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared.
|
Baseline, Week 4, and Week 9
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Hatice Kübra Aras, Antalya Bilim University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2020
Primärt slutförande (Faktisk)
25 november 2021
Avslutad studie (Faktisk)
20 januari 2022
Studieregistreringsdatum
Först inskickad
16 juli 2026
Först inskickad som uppfyllde QC-kriterierna
21 juli 2026
Första postat (Faktisk)
23 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Tarmsjukdomar
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Kolonsjukdomar, funktionella
- Irritabel tarmsyndrom
- Ångeststörningar
- Terapeutik
- Diet, mat och näring
- Fysiologiska fenomen
- Kolhydrater
- Näringsfysiologiska fenomen
- Dieterapi
- Näringsterapi
- Diet
- Polysackarider
- Disaccharides
- Oligosackarider
- Socker
- Eliminationsdieter
- Fodmap -diet
- Diet, glutenfri
- Laktos
Andra studie-ID-nummer
- 2020/034
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .