Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup

Universitaire Ziekenhuizen KU Leuven

Status and phase

Completed

Phase 4

Conditions

Functional Dyspepsia

Postprandial Fullness Syndrome

Treatments

Drug: Itopride

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04647955

LPDSItopride

Details and patient eligibility

About

Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. At present, no validated instrument is available for the assessment of the symptom responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have previously conducted focus group sessions and cognitive interviews in PDS patients to identify all relevant symptom items that characterize PDS. In this study we aim to validate the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its consistency, reliability and ability to detect change in the framework of a controlled treatment trial.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see appendix 1B)
Patients must provide witnessed written informed consent prior to any study procedures being performed
Patients aged between 18 and 70 years inclusive
Male or female patients
Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements

Exclusion criteria

Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). Patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline) during the last 3 months are eligible.
Females who are pregnant or lactating.
Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months.
Patients suffering from diabetes type 1 or type 2.
Patients taking medication for functional dyspepsia will need a wash-out period of 2 weeks before they can be screened
Patients with known hypersensitivity to gastroprokinetic drugs.
Patients with confirmed gastro-intestinal disease.
Patients with former digestive surgery affecting upper gut motility.
Patients affected by concomitant disease responsible for digestive symptoms
Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
Patients presenting symptoms of EPS several times a week according to Rome III questionnaire
Patients presenting daily symptoms of CIN on Rome III questionnaire
Patients presenting vomiting more than one day a month.
Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire
Patients presenting predominant GERD according to GERD questionnaire