Status:
NOT_YET_RECRUITING
Postprandial Distress Itopride Cohort Trial
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Postprandial Distress Syndrome
Functional Dyspepsia
Eligibility:
All Genders
18+ years
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07165301
Start Date
October 1 2025
End Date
July 31 2026
Last Update
September 10 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Belgium, 3000