Postprandial Distress Itopride Cohort Trial
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient diagnosed with functional dyspepsia as per physician clinical criteria
Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose and procedures required for the study and is willing to participate in the study.
Patient must speak Dutch or French
Disqualifiers
Patient with other clinical diagnosis than functional dyspepsia that can explain their gastrointestinal symptoms.
Any abdominal surgery within the 3 months prior to screening;
Subject has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, cholecystectomy, or polypectomy more than 3 months earlier are allowed).
Patient has an unstable cardiac, pulmonary, renal, hepatic, metabolic, or hematologic condition.
Trial population
Participants are recruited in Belgium at gastroenterology outpatient clinics when their treating gastroenterologist decides to initiate itopride as part of standard clinical care for functional dyspepsia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Functional dyspepsia patients
Trial outcomes
Primary outcomes
1
PAGI-SYM improvement
The primary endpoint for this study is symptom improvement at week 8. For this, the symptomatic improvement as assessed by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) compared to baseline will be evaluated for each symptomatic domain (heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, lower abdominal pain) where a MCID has been previously been established.
Time frame
8 weeksSecondary outcomes
1
Symptom Improvement
Symptom evolution will be assessed using the PAGI-SYM questionnaire. The PAGI-SYM will be administered at baseline, week 8, and week 16 to evaluate changes in individual gastrointestinal symptoms over time. Previously established minimal clinically important differences (MCIDs) will be used to aid in the interpretation of changes.
Time frame
From baseline to +16 weeks (end of trial)2
Perceived Treatment Effectiveness
Perceived treatment effectiveness will be assessed using the Overall Treatment Evaluation (OTE) questionnaire. The OTE will be assessed at visit 1 and visit 2 to capture the patient's subjective sense treatment effectiveness. Together with the PAGI-SYM questionnaire, these instruments will provide both objective and patient-perceived measures of symptom change during the study period.
Time frame
From baseline to +16 weeks (end of trial)3
Health-economic evaluation: WPAI
Health-economic outcomes will be assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. This instrument will be used to evaluate changes in work productivity related to gastric symptoms. Together with the EuroQol 5 Dimension 5 Level (EQ-5D-5L) and Health Resource Utilization (HRU) questionnaires, these data will be used to assess the economic impact of the intervention.
Time frame
-6 months to +16 weeks (end of trial)4
Health-economic evaluation and quality of life: EQ-5D-5L
Health-economic outcomes and quality of life will be assessed using the EQ-5D-5L questionnaire. This instruments will be used to evaluate changes in health-related quality of life related to gastric symptoms. Quality-adjusted life years (QALYs) will be calculated based on EQ-5D-5L responses to support cost-utility analysis.
Time frame
-6 months to +16 weeks (end of trial)Sponsors and contacts
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Source ClinicalTrials.gov
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