Postprandial Distress SyndromePASSPORTNCT07165301
Postprandial Distress Itopride Cohort Trial
An observational study of Postprandial Distress Syndrome and Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postprandial Distress Syndrome, Functional Dyspepsia, Epigastric Pain Syndrome
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
UZ Leuven
Leuven, 3000
Jan Tack, MD, 16 34 42 25 ext. 32, jan.tack@kuleuven.be
Janne Scheepers, MPharm, 16 32 89 61 ext. +32, janne.scheepers@kuleuven.be
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: 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.
Measured: 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.
Measured: From baseline to +16 weeks (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study startOct 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165301
- Sponsor's protocol ID
- S70891
- Acronym
- PASSPORT
- Status last verified
- Jul 2025
- First submitted
- 20 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Functional Dyspepsia/Postprandial Distress Syndrome Patients Treated With Itopride
- ClinicalTrials.gov ID
- NCT07165301
- Acronym / sponsor ID
- PASSPORT / S70891
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Patient with other clinical diagnosis than functional dyspepsia that can explain their gastrointestinal symptoms.
- Patient has any of the following surgical history:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Symptom Improvement
Time frame: From baseline to +16 weeks (end of trial)
Perceived Treatment Effectiveness
Time frame: From baseline to +16 weeks (end of trial)
Health-economic evaluation: WPAI
Time frame: -6 months to +16 weeks (end of trial)
Health-economic evaluation and quality of life: EQ-5D-5L
Time frame: -6 months to +16 weeks (end of trial)
Health-economic evaluation: HRU
Time frame: -6 months to +16 weeks (end of trial)
Quality of life evaluation
Time frame: From baseline to +16 weeks (end of trial)
Treatment compliance
Time frame: From +8 weeks to +16 weeks (end of trial)
Baseline characteristics
Time frame: From baseline to +16 weeks (end of trial)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postprandial Distress Syndrome and Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Tack, MD (16 34 42 25 ext. +32, jan.tack@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAGI-SYM improvement (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.