Postprandial Distress Itopride Cohort Trial (PASSPORT)

Prospective Cohort Study of Functional Dyspepsia/Postprandial Distress Syndrome Patients Treated With Itopride

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Dyspepsia; Epigastric Pain Syndrome; Postprandial Distress Syndrome

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jan Tack, MD; Phone Number: +32 16 34 42 25; Email: jan.tack@kuleuven.be
• Study Contact Backup: Name: Janne Scheepers, MPharm; Phone Number: +32 16 32 89 61; Email: janne.scheepers@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
    • Principal Investigator: Jan Tack, MD
    • Contact: Janne Scheepers, MPharm; Phone Number: +32 16 32 89 61; Email: janne.scheepers@kuleuven.be
    • Contact: Jan Tack, MD; Phone Number: 32 16 34 42 25; Email: jan.tack@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient with other clinical diagnosis than functional dyspepsia that can explain their gastrointestinal symptoms.

• Patient has any of the following surgical history:

  • 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.
• Patient has a history of active malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
• Patient has received an investigational drug or used an investigational medical device within 30 days prior to randomization, or is currently enrolled in an investigational study.
• In case of psychotropic drug use: patient NOT on stable doses of antidepressants (i.e., for the 3 months prior to pre-screening) will not be allowed to participate in the study. Habitual use of benzodiazepines is permitted.
• Patient is pregnant or breastfeeding.
• Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Functional dyspepsia patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to +16 weeks (end of trial)
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.	From baseline to +16 weeks (end of trial)
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.	-6 months to +16 weeks (end of trial)
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.	-6 months to +16 weeks (end of trial)
Health-economic evaluation: HRU	Health-economic outcomes will be assessed using the HRU questionnaire. This instrument will be used to evaluate changes in healthcare resource utilization related to gastric symptoms.Health resource use will be collected retrospectively for the 6 months prior to baseline and prospectively throughout the study to estimate direct medical costs.	-6 months to +16 weeks (end of trial)
Quality of life evaluation	Quality of life will be assessed using the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) questionnaire at baseline, week 8, and week 16. This instrument will be used to evaluate the specific impact of gastrointestinal symptoms on daily functioning and well-being.	From baseline to +16 weeks (end of trial)
Treatment compliance	Treatment adherence will be assessed through self-report, and expressed as the proportion of prescribed doses taken during the study period. Compliance will be analyzed descriptively and explored as a potential factor influencing treatment outcomes.	From +8 weeks to +16 weeks (end of trial)
Baseline characteristics	Baseline characteristics include medical history and demographic parameters (age, sex, weight, length, BMI). Baseline economic impact will be assessed by the Health resource utilisation (HRU) questionnaire.	From baseline to +16 weeks (end of trial)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: September 2, 2025
• First Posted (Estimated): September 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: S70891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No