Online Low-FODMAP Diet in Irritable Bowel Syndrome

NCT07172581 | Completed

• 1 other identifier: 19.304
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess the impact of implementing the low Fermentable Oligo-, Di- and Monosaccharides, And Polyols (FODMAP) diet, through an online educational service platform, on the quality of life of patients living with irritable bowel syndrome (IBS). A prospective single-group intervention pilot study involving patients with IBS from two hospitals was conducted. Participants followed the low FODMAP diet using a web-based platform for 6 months. The IBS quality of life questionnaire (IBS-QoL), the IBS symptom severity scoring system (IBS-SSS) and the State-Trait Anxiety Inventory Form Y (STAI) were completed at baseline, after the restriction phase and after reintroduction phase.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• IBS-related quality of life

  The primary outcome was the change in QoL from baseline to the end of study, assessed by the validated IBS-QoL questionnaire. This questionnaire assesses 8 domains, namely dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual concerns and relationships, from which a computed score is drawn. This score, ranging from 0 to 100, was developed to assess the self-reported QoL in IBS, a higher score indicating a better QoL.

  From enrollment to the end of intervention at 6 months.

Secondary Outcomes (2)

• Severity of IBS symptoms

  From enrollment to the end of intervention at 6 months.

• State and trait anxiety

  From enrollement to the end of intervention at 6 months.

Study Arms (1)

Online low-FODMAP diet

EXPERIMENTAL

An innovative approach was developed by the SOSCuisine® platform, an online menu service adapted to different conditions, including IBS. It enables people living with IBS to follow the FODMAP protocol in a self-service context, using online resources of personalized weekly low-FODMAP menus, instructions for each phase and a peer support group moderated by a specialized registered dietitian.

Behavioral: Online low-FODMAP diet

Interventions

Online low-FODMAP diet BEHAVIORAL

Participants were invited to follow the online low-FODMAP diet offered by SOSCuisine®, characterized by three specific features. First, participants received customized weekly low-FODMAP menus based on the Monash University protocol. Second, a virtual assistant accompanied participants from the beginning to the end of the diet implementation, providing personalized recommendations tailored to individual's preferences and intensity of symptoms. For the reintroduction phase, the assistant guided individuals through the process of testing specific FODMAP subgroups, offering food suggestions based on individual preferences, and portion sizes. The last feature of the platform was the access to a peer support group on Facebook©, designed to foster communication among participants. This group allowed individuals to ask questions and receive valid answers, as the group was moderated by a FODMAP-specialized registered dietitian.

Online low-FODMAP diet

Eligibility Criteria

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

You may qualify if:

• have a diagnosis of IBS according to the Rome IV criteria by a gastroenterologist within the past three months
• understand French
• have an Internet access and a Facebook© account with a self-reported familiarity to use them

You may not qualify if:

• patients suffering from a known eating or mental health disorder
• body mass index under 18.5 kg/m2
• type 1 or 2 diabetes
• pregnancy
• other chronic gastrointestinal diseases, except gastroesophageal reflux

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre de recherche du Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: May 23, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)