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NCT07165301: PASSPORT
Prospective Cohort Study of Functional Dyspepsia/Postprandial Distress Syndrome Patients Treated With Itopride
trial in Postprandial Distress Syndrome in 200 participants. Not yet recruiting.
31 July 2026
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 October 2025 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 1 location across Belgium |
Conditions studied
- Postprandial Distress Syndrome — all drugs for Postprandial Distress Syndrome →
- Functional Dyspepsia — all drugs for Functional Dyspepsia →
- Epigastric Pain Syndrome — all drugs for Epigastric Pain Syndrome →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
18 and older, any sex, with Postprandial Distress Syndrome or Functional Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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) wh
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07165301
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Postprandial Distress Syndrome
Currently open trials in the same condition.
- NCT06696261 — A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome · Phase 3 · recruiting
- NCT06482671 — Primary Care dySpEpsia rikkuNshiTo · Phase 3 · recruiting
Other Universitaire Ziekenhuizen KU Leuven trials
Trials by the same sponsor.
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- NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
- NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
- NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07165301 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07165301.
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