Postprandial Distress Itopride Cohort Trial

Functional Dyspepsia (FD) is a common gastrointestinal disorder affecting about 7.2% of the population, characterized by gastroduodenal symptoms without an identifiable organic cause. It is divided into two subtypes based on the Rome IV criteria: (i) Postprandial Distress Syndrome (PDS): Meal-related symptoms like postprandial fullness and early satiation.; (ii) Epigastric Pain Syndrome (EPS): Meal-unrelated symptoms like epigastric pain or burning. Treatment options are limited, but prokinetics are commonly used, targeting suspected motility issues. A meta-analysis showed prokinetics reduce symptoms. Itopride, a D2 antagonist and acetylcholinesterase inhibitor, has shown potential efficacy, especially in Asian populations. As Itopride became available in Belgium since 2023, there is a lack of real-life outcome data in Western patients with functional dyspepsia/postprandial distress syndrome who receive treatment in standard clinical practice. Hence, the aim of this pragmatic observational study is to follow up a cohort of functional dyspepsia/postprandial distress syndrome patients in whom itopride treatment is started as part of routine clinical practice.

NCT Number	NCT07165301
Lead Sponsor	Universitaire Ziekenhuizen KU Leuven
Conditions	Postprandial Distress Syndrome, Functional Dyspepsia, Epigastric Pain Syndrome
Enrollment	200 participants
Start Date	2025-10
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-10