The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers
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 gluten-free diet.

      To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind,
      placebo-controlled cross-over trial will be carried out in adults (>18) and patients with IBS
      according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet
      in IBS patients and Healthy Volunteers.
    

Detailed description: 
      The study is a randomized, double-blind, placebo-controlled, cross-over trial.

      The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet
      (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral
      sensitivity, bacterial fermentation, psychological factors and quality of life. The primary
      hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this
      change is accompanied with reduced visceral sensitivity and change in bacterial fermentation.
      The secondary hypothesis is that GFD positively influences psychological factors and quality
      of life.

      IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized,
      double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over
      to the other intervention (both for 14 days). In between there is a wash-out period of at
      least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to
      sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or
      placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods.
      The subjects will eat and drink as before the study during the washout period.

      Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires,
      including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom 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 quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and
      VSI.
    

Intervention name(s): Gluten-free diet with gluten powder; Gluten-free diet with placebo powder
Intervention type(s): Other; Other
Intervention description(s): The subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).; The subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled, Cross-over Trial
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: gluten-free diet; gluten-containing diet; microbiota; metabolomics; healthy volunteers