Functional dyspepsia unexplainable stomach complaints
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients with functional dyspepsia * A diagnosis of functional dyspepsia according to Rome IV criteria (2): - One or more of the following: - Bothersome postprandial fullness - Bothersome early satiation - Bothersome epigastric pain - Bothersome epigastric burning AND - No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms. - Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. * Age between 18 and 75 years; * Ability to understand and speak the Dutch language; * Ability to understand how to utilize the ESM tool. Inclusion criteria for healthy volunteers * Age between 18 and 75 years * Ability to understand and speak the Dutch language * Ability to understand how to utilize the ESM tool.
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients with functional dyspepsia * Any organic explanation for the gastrointestinal complaints; * Initiation of regularly used medication from one month before inclusion until the end of study participation; * A history of upper digestive surgery influencing end points * A history of radiation therapy of the abdomen * Pregnancy Exclusion criteria for healthy volunteers * Current diagnosis of any gastrointestinal disorder * Current gastrointestinal symptoms suiting the ROME IV criteria for FD * Initiation of regularly used medication from one month before inclusion until the end of study participation * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study outcome comprehends the psychometric properties of the PROM for symptom assessment in functional dyspepsia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are associations between the presence of psychosocial and environmental factors (e.g. as measured by the PROM) and an increase in ESM score for gastrointestinal symptoms from one time point (t-1) to the next (t). | — |
Countries
Netherlands
Outcome results
None listed