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

NCT ID: NCT03423069

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2020-12-31

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diet low in FODMAPs

Diet low in FODMAPs (diet A) during 12 weeks (with intermediate nutritional checks every 4 weeks) before returning to the final study visit.

Group Type: EXPERIMENTAL

Diet low in FODMAPs

Intervention Type: DIETARY_SUPPLEMENT

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.

Specific dietary advice for IBS

Dietary advice for IBS (diet B) during 12 weeks (with intermediate nutritional checks every 4 weeks) before returning to the final study visit.

Group Type: ACTIVE_COMPARATOR

Specific dietary advice for IBS

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Diet low in FODMAPs

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.

Intervention Type: DIETARY_SUPPLEMENT

Specific dietary advice for IBS

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Riezzo

Senior investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Russo

Role: PRINCIPAL_INVESTIGATOR

National Institute for Digestive Diseases IRCCS " Saverio de Bellis"

Locations

IRCCS Saverio de Bellis

Castellana Grotte, Bari, Italy

Countries

Italy

References

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Reference Type: DERIVED

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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.

Reference Type: DERIVED

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Other Identifiers

RC2018B

Identifier Type: -

Identifier Source: org_study_id