Postprandial Distress Itopride Cohort Trial

NCT ID: NCT07165301

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-07-31

Brief 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. 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.

Conditions

Postprandial Distress Syndrome; Functional Dyspepsia; Epigastric Pain Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Functional dyspepsia patients

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Central Contacts

Jan Tack, MD

Role: CONTACT

jan.tack@kuleuven.be

16 34 42 25 ext. +32

Janne Scheepers, MPharm

Role: CONTACT

janne.scheepers@kuleuven.be

16 32 89 61 ext. +32

Facility Contacts

Jan Tack, MD

Role: primary

jan.tack@kuleuven.be

16 34 42 25 ext. 32

Janne Scheepers, MPharm

Role: backup

janne.scheepers@kuleuven.be

16 32 89 61 ext. +32

Other Identifiers

S70891

Identifier Type: -

Identifier Source: org_study_id