Postprandial Distress Itopride Cohort Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postprandial Distress Syndrome, Functional Dyspepsia, Epigastric Pain Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study of Functional Dyspepsia/Postprandial Distress Syndrome Patients Treated With Itopride
Overview
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.
Primary outcome measures
- PAGI-SYM improvement [Time frame: 8 weeks]
Secondary outcome measures (8)
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- UZ Leuven — Leuven
Identifiers
NCT: NCT07165301 · S70891