Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides,
      and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so
      far few randomized trials have reported data in favor of the effective therapeutic
      superiority of a low-FODMAPs diet compared to specific IBS dietary advice. On this basis, the
      present study is aimed, in a multidisciplinary perspective, at investigating possible changes
      in the symptom profile and intestinal permeability, GI peptides concentrations, metabolic and
      lipidomic profiles induced by these different diets in patients with IBS diarrheal variant.
    

Detailed description: 
      Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease (GI) affecting 10%
      -20% of the population and is composed of abdominal pain/discomfort, in combination with
      alterations of the stool habit. This is a functional disorder prevalent in Italy with double
      percentages in urban areas (13.7%) compared to rural ones (5.9%). IBS is still one of the
      main reasons for patients to seek for gastroenterological advice. The diagnosis of IBS is
      mainly based on the evaluation of symptom profiles by using different scales of assessment
      and also taking into account non-GI symptoms (e.g. insomnia, anxiety, and depression), as
      well as the characteristics of the stools. IBS is classified in different subtypes, namely:
      IBS diarrheal variant (IBS-D), IBS with constipation (IBS-C), IBS mixed variant (IBS-M) and
      non-classifiable. The pathophysiology is only partially understood and an abnormal motility,
      together with alterations in gut-brain communication, a low-grade inflammation, and
      psychosocial factors, have been variously involved. On the other hand, the therapeutic
      choices are still scarce. The majority of IBS subjects believe that some foods are
      responsible for their symptoms, tending to exclude them without, however, compromising their
      nutritional status [14]. Many dietary approaches have been proposed, but only a few
      controlled studies have been performed in this field. Recent evidence suggests that the
      intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs)
      may trigger GI symptoms in patients with IBS. These carbohydrates are poorly absorbed in the
      small intestine and can pass intact in the colon, where they increase the endoluminal water
      through the osmotic activity and induce the production of gas due to their fermentation by
      intestinal bacterial flora. This, in turn, can cause abdominal distension and diarrhea. Data
      in the literature suggest that a diet with a reduced content in FODMAPs may be beneficial for
      patients with IBS and diarrhea, but so far few randomized trials have reported data in favor
      of the effective superiority of a low-FODMAPs diet compared to the specific dietary advice
      for patients with IBS. On this basis, the present study is aimed at comparing these two diets
      in a randomized, single-blind clinical trial in IBS patients with diarrhea.
    

Intervention name(s): Diet low in FODMAPs; Specific dietary advice for IBS
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A strict restriction of all high FODMAP foods for the time of observation. All these foods will be identified by appropriate nutritional visits and alternatives will be suggested to ensure the diet is nutritionally adequate.; Dietary recommendations such as limitation of alcohol, spicy food and fatty foods, caffeine, carbonated drinks; avoidance of chewing gums and sweeteners containing polyols; small and frequent meals; avoidance of stressful conditions and eating slowly.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single blind clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; FODMAPs; Dietary advice; Gastrointestinal symptoms; Intestinal permeability; Gastrointestinal peptides; Microbiome; Lipidomic profile