Irritable Bowel SyndromeNCT07172581
Online Low-FODMAP Diet in Irritable Bowel Syndrome
A study testing Online low-FODMAP diet in people with Irritable Bowel Syndrome, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Online low-FODMAP diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 23 May 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
About this study
Official 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
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
- Being tested
- Online low-FODMAP diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online low-FODMAP dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online low-FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at 6 months.
Secondary outcomes (2)
Severity of IBS symptoms
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).
Measured: From enrollment to the end of intervention at 6 months.
State and trait anxiety
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.
Measured: From enrollement to the end of intervention at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start23 May 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172581
- Sponsor's protocol ID
- 19.304
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07172581
- Acronym / sponsor ID
- 19.304
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online low-FODMAP diet | Experimental | Behavioral: Online low-FODMAP dietAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online low-FODMAP dietParticipants 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. | Behavioural | Online low-FODMAP diet |
Primary outcome
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.
2 secondary outcomes
Severity of IBS symptoms
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online low-FODMAP diet in people with Irritable Bowel Syndrome, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-related quality of life (time frame: From enrollment to the end of intervention at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.