An observational study in Irritable Bowel Syndrome, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by Maastricht University Medical Center · Observational
Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 184 is above the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
IBS patients.
Exclusion Criteria:
IBS according to Rome IV criteria.
Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS.
Abdominal pain scores as measured by the ESM tool.
Momentary measurements.
Time frame: 7 days
Abdominal pain scores as measured by the end-of-day diary.
Retrospective measurements with a recall period of one day.
Time frame: 7 days
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.
Retrospective measurements with a recall period of one week.
Time frame: 7 days
Symptom scores (other than abdominal pain) as measured using the ESM-tool.
Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment.
Time frame: 7 days
Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.
Time frame: 7 days
Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.
Time frame: 7 days
Psychological symptom scores as measured using the PHQ-9.
Time frame: 7 days
Psychological symptom scores as measured using the GAD-7.
Time frame: 7 days
Quality of life scores as measured using SF-36.
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center