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Postprandial Distress Itopride Cohort Trial

NCT07165301 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-09-10

No results posted yet for this study

Summary

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.

Conditions

  • Postprandial Distress Syndrome
  • Functional Dyspepsia
  • Epigastric Pain Syndrome

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07165301 on ClinicalTrials.gov