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

NCT03423069 | Completed

• 1 other identifier: RC2018B
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; FODMAPs; Dietary advice; Gastrointestinal symptoms; Intestinal permeability; Gastrointestinal peptides; Microbiome; Lipidomic profile

Outcome Measures

Primary Outcomes (1)

• Change in the total score of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire

  IBS-SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS), leading to a total possible score of 500. The primary outcome corresponds to a change in the total score of the IBS-SSS questionnaire at the end of the treatment period compared to baseline, and the proportion of patients who will achieve a difference in the total symptom score of IBS-SSS ≥50 after diet. Such difference is considered a significant clinical improvement.

  Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).

Secondary Outcomes (4)

• Change in the score of the single symptom items of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire

  Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).

• Change in the intestinal permeabily evaluation

  Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).

• Change in the GI peptide concentrations

  Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).

• Change in the lipidomic profile.

  Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).

Study Arms (2)

Diet low in FODMAPs

EXPERIMENTAL

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

Dietary Supplement: Diet low in FODMAPs

Specific dietary advice for IBS

ACTIVE COMPARATOR

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

Dietary Supplement: Specific dietary advice for IBS

Interventions

Diet low in FODMAPs 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.

Diet low in FODMAPs

Specific dietary advice for IBS 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.

Specific dietary advice for IBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must be willing to change their current diet to participate in the study for the whole study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

IRCCS Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (9)

• Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.

  PMID: 22426087 BACKGROUND

• Mearin Manrique F. Irritable bowel syndrome (IBS) subtypes: Nothing resembles less an IBS than another IBS. Rev Esp Enferm Dig. 2016 Feb;108(2):57-8. doi: 10.17235/reed.2016.4195/2016.

  PMID: 26838485 BACKGROUND

• Gonzalez-Castro AM, Martinez C, Salvo-Romero E, Fortea M, Pardo-Camacho C, Perez-Berezo T, Alonso-Cotoner C, Santos J, Vicario M. Mucosal pathobiology and molecular signature of epithelial barrier dysfunction in the small intestine in irritable bowel syndrome. J Gastroenterol Hepatol. 2017 Jan;32(1):53-63. doi: 10.1111/jgh.13417.

  PMID: 27087165 BACKGROUND

• Mazzawi T, El-Salhy M. Changes in duodenal enteroendocrine cells in patients with irritable bowel syndrome following dietary guidance. Exp Biol Med (Maywood). 2017 Jul;242(13):1355-1362. doi: 10.1177/1535370217699537. Epub 2017 Mar 17.

  PMID: 28737477 BACKGROUND

• Shepherd SJ, Lomer MC, Gibson PR. Short-chain carbohydrates and functional gastrointestinal disorders. Am J Gastroenterol. 2013 May;108(5):707-17. doi: 10.1038/ajg.2013.96. Epub 2013 Apr 16.

  PMID: 23588241 BACKGROUND

• 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.

  PMID: 24076059 BACKGROUND

• McKee AM, Prior A, Whorwell PJ. Exclusion diets in irritable bowel syndrome: are they worthwhile? J Clin Gastroenterol. 1987 Oct;9(5):526-8. doi: 10.1097/00004836-198710000-00007.

  PMID: 3680901 BACKGROUND

• Linsalata M, Prospero L, Ignazzi A, Riezzo G, D'Attoma B, Mallardi D, Goscilo F, Notarnicola M, De Nunzio V, Pinto G, Russo F. Depression in Diarrhea-Predominant IBS Patients: Exploring the Link Between Gut Barrier Dysfunction and Erythrocyte Polyunsaturated Fatty Acid Levels. J Clin Med. 2025 Apr 5;14(7):2483. doi: 10.3390/jcm14072483.

  PMID: 40217932 DERIVED

• 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.

  PMID: 34022802 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Francesco Russo

  National Institute for Digestive Diseases IRCCS " Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior investigator

Model Details: Randomized, single blind clinical trial

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 6, 2018
• Study Start: February 5, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 31, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)