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NCT Number: NCT07165301

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.

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Key information

Conditions

Postprandial Distress Syndrome Epigastric Pain Syndrome Functional Dyspepsia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PAGI-SYM improvement

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Symptom Improvement

    Time frame: From baseline to +16 weeks (end of trial)

    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.

  2. Perceived Treatment Effectiveness

    Time frame: From baseline to +16 weeks (end of trial)

    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.

  3. Health-economic evaluation: WPAI

    Time frame: -6 months to +16 weeks (end of trial)

    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.

  4. Health-economic evaluation and quality of life: EQ-5D-5L

    Time frame: -6 months to +16 weeks (end of trial)

    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.

  5. Health-economic evaluation: HRU

    Time frame: -6 months to +16 weeks (end of trial)

    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. Quality of life evaluation

    Time frame: From baseline to +16 weeks (end of trial)

    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.

  7. Treatment compliance

    Time frame: From +8 weeks to +16 weeks (end of trial)

    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.

  8. Baseline characteristics

    Time frame: From baseline to +16 weeks (end of trial)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Tack, MD

CONTACT

[email protected]

16 34 42 25 ext. +32

Janne Scheepers, MPharm

CONTACT

[email protected]

16 32 89 61 ext. +32

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: PASSPORT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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