Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant — DIETSINIBS  

Irritable Bowel Syndrome Clinical Trial

Official title: Effects of a Diet Low in Fructose, Oligosaccharides, Disaccharides, Monosaccharides, Alcohols and Polyols in Patients With Irritable Bowel Syndrome Diarrheal Variant Respect to Dietary Advice: Randomized, Single Blind Clinical Trial.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

• NCT number: NCT03423069
• Study type: Interventional
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Completion date: December 31, 2020