Postprandial Distress Itopride Cohort Trial

NCT07165301 | Not Yet Recruiting

• 1 other identifier: S70891
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (8)

• Symptom Improvement

  From baseline to +16 weeks (end of trial)

• Perceived Treatment Effectiveness

  From baseline to +16 weeks (end of trial)

• Health-economic evaluation: WPAI

  -6 months to +16 weeks (end of trial)

• Health-economic evaluation and quality of life: EQ-5D-5L

  -6 months to +16 weeks (end of trial)

• Health-economic evaluation: HRU

  -6 months to +16 weeks (end of trial)

Study Arms (1)

Functional dyspepsia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Central Study Contacts

Jan Tack, MD

CONTACT

16 34 42 25; jan.tack@kuleuven.be

Janne Scheepers, MPharm

CONTACT

16 32 89 61; janne.scheepers@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-07

Locations

BE (1)