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Completed

NCT Number: NCT07172581

Online Low-FODMAP Diet in Irritable Bowel Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Montreal, Quebec, H2X 0A9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. IBS-related quality of life

    Time frame: From enrollment to the end of intervention at 6 months.

    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.

Secondary outcomes

  1. Severity of IBS symptoms

    Time frame: From enrollment to the end of intervention at 6 months.

    Secondary outcomes included changes in severity of IBS symptoms, measured by the validated IBS-Severity Scoring System (IBS-SSS). This questionnaire evaluates 5 specific domains within the last ten days: abdominal pain severity, abdominal pain duration, abdominal distension, bowel habits dissatisfaction and interference with life. A composite score is calculated and varies from 0 to 500. Depending on the score, the severity can be classified in 4 categories: absence of symptoms severity or remission (score < 75), mild (score 75-174), moderate (score 175-299), and severe (score ≥ 300).

  2. State and trait anxiety

    Time frame: From enrollement to the end of intervention at 6 months.

    Anxiety was evaluated by the French-Canadian adaptation of the State-Trait Anxiety Inventory Form Y (STAI), which specifically assesses state anxiety (STAI-S), the subjective and transient emotional state of anxiety, and trait anxiety (STAI-T), a more stable predisposition to anxiety. The STAI-S score can be classified in 5 categories: very low state anxiety (score < 36), low (score 36-45), moderate (score 46-55), high (score 56-65), and very high (score > 65). For the STAI-T score, a score inferior to 40 commonly indicates low trait anxiety while a score of 40 or more indicates high trait anxiety.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

Impact of an Online Service Offering Personalized Low-FODMAP Menus With Nutritional Support on Quality of Life and Control of Physical and Psychological Symptoms in People With Irritable Bowel Syndrome

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 15, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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