The Effects of FODMAPs in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in
      dietary management recently increased, including the use of a low FODMAP diet.

      To investigate relation of FODMAPs and IBS, a randomized, double-blind, cross-over trial will
      be carried out in adult (>18) patients with IBS according to Rome IV criteria. The aim is to
      assess low FODMAP diet versus moderate/high FODMAP diet in IBS patients.
    

Detailed description: 
      The study is a randomized, double-blind, cross-over trial.

      The aim is to assess the effects of low fermentable oligosaccharides, disaccharides,
      monosaccharides and polyols (FODMAP) diet compared to moderate/high FODMAP diet in IBS
      patients on gastrointestinal symptoms and psychological factors. The primary hypothesis is
      that the low FODMAP diet decreases gastrointestinal symptoms compared to moderate/high FODMAP
      diet, and that this change is accompanied with reduced psychological distress.

      IBS patients (Rome IV) are challenged with FODMAPs in this randomized, double-blinded,
      cross-over study. The subjects will start with the low FODMAP diet or moderate/high FODMAP
      diet and cross over to the other intervention (both for 7 days). In between the
      interventions, there is a wash-out period of at least 14 days. The subjects will receive
      ready-made meals from the hospital kitchen (lunch and dinner) and in between snacks. The
      subjects are instructed to buy breakfast themselves and the subjects will receive information
      on which other foods to avoid, without mentioning 'FODMAPs'. The subjects will follow their
      usual diet (as before initiation of the study) during the wash-out period.

      Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires,
      including IBS Severity Scoring System (IBS-SSS) (7-10 day recall and modified daily) and
      Gastrointestinal Symptom Rating Scale -IBS (GSRS-IBS). A 50-point reduction in IBS-SSS
      indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and
      visceral sensitivity will be measured using the Lactulose Nutrient Challenge Test. Secondary
      outcomes are change in psychological factors and assessed by questionnaires, including
      Central Sensitization Index (CSI), Hospital Anxiety and Depression Scale (HADS), Patient
      Health Questionnaire (PHQ)-15 and Visceral Sensitivity Index (VSI).
    

Intervention name(s): Diet moderate/high in FODMAPs; Diet low in FODMAPs
Intervention type(s): Other; Other
Intervention description(s): The subjects will obtain meal boxes prepared in the hospital kitchen with a moderately high FODMAP content (23 grams/day); The subjects will obtain meal boxes prepared in the hospital kitchen with a low FODMAP content (<5 grams/day)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Double-blind, Cross-over Trial
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: FODMAPs; carbohydrates; gastrointestinal symptoms; IBS