Postprandial Distress Itopride Cohort Trial (PASSPORT)

Universitaire Ziekenhuizen KU Leuven

Status: Not yet enrolling

Conditions: Functional Dyspepsia; Epigastric Pain Syndrome; Postprandial Distress Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT07165301

S70891

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Functional dyspepsia patients