Clinical trial NCT03423069: Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
FODMAPs
Dietary advice
Gastrointestinal symptoms
Intestinal permeability
Gastrointestinal peptides
Microbiome
Lipidomic profile
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single blind clinical trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Rome IV criteria for IBS diarrhea variant (IBS-D).
* Low-lactose diet is allowed, provided that patients agree to keep this intake constant throughout the study period, except in the case of randomization in the treatment arm with a low-FODMAPs diet.
* The use of probiotic products is permitted, and patients who consume probiotic products must be instructed to continue taking the same amount previously taken throughout the study period.
* The drugs used to treat IBS, including antidepressants, will be admitted provided they are used regularly and have a stable dosage for at least one month prior to inclusion in the study.
* Patients must be willing to change their current diet to participate in the study for the whole study period.

Exclusion Criteria:

* Serious cardiac, hepatic, neurological or psychiatric diseases.
* GI diseases other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain current symptoms.
* Patients who previously had a low-content diet of particular substances (for example, low FODMAPs content, vegan diet, gluten-free diet). - This last category of subjects will be able to return to the study provided they suspend the gluten-free diet until thes symptoms reappear.

Primary outcomes:
measure: Change in the total score of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire
timeFrame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Secondary outcomes:
measure: Change in the score of the single symptom items of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire
timeFrame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
measure: Change in the intestinal permeabily evaluation
timeFrame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
measure: Change in the GI peptide concentrations
timeFrame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
measure: Change in the lipidomic profile.
timeFrame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: IRCCS Saverio de Bellis
state: Bari
Study officials:
affiliation: National Institute for Digestive Diseases IRCCS " Saverio de Bellis"
name: Francesco Russo
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
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citation: Prospero L, Riezzo G, Linsalata M, Orlando A, D'Attoma B, Di Masi M, Martulli M, Russo F. Somatization in patients with predominant diarrhoea irritable bowel syndrome: the role of the intestinal barrier function and integrity. BMC Gastroenterol. 2021 May 22;21(1):235. doi: 10.1186/s12876-021-01820-7.