Online Low-FODMAP Diet in Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT07172581
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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 of tolerated FODMAPs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method IBS-related quality of life 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 Outcome Measures
Name Time Method Severity of IBS symptoms 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) (Francis et al., 1997). 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).
State and trait anxiety 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) (Gauthier and Bouchard, 1993; Spielberger, 1983), 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) (Bauer et al., 2016). 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 (Kose et al., 2021).
Trial Locations
- Locations (1)
Centre de recherche du Centre Hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
Centre de recherche du Centre Hospitalier de l'Université de Montréal🇨🇦Montreal, Quebec, Canada