Online Low-FODMAP Diet in Irritable Bowel Syndrome

September 16, 2025 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre de recherche du Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online low-FODMAP diet
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of intervention at 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of intervention at 6 months.
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.
From enrollement to the end of intervention at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19.304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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