ESM in Functional Dyspepsia (MEASuRE-D)
Dyspepsia, Dyspepsia and Other Specified Disorders of Function of Stomach
About this trial
This is an interventional diagnostic trial for Dyspepsia
Eligibility Criteria
Both patients with functional dyspepsia (36) as healthy controls (36) will be included
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 (confirmed by 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 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 controls:
- 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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Experimental
Experience Sampling Method (ESM)
Both patients with functional dyspepsia and healthy controls will be asked to fill out ESM questionnaires during 1 week. Moreover, at the end of this week, usual questionnaires for complaints assessment will be filled out.