Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Completed

• Conditions: Joint Hypermobility Syndrome; Functional Dyspepsia

• Registration Number: NCT04279990
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Functional dyspepsia (FD) is defined as the presence of gastroduodenal symptoms in the absence of organic disease that is likely to explain the symptoms. Joint hypermobility (JH) refers to the increased passive or active movement of a joint beyond its normal range. Recent reports have highlighted the co-existence of FD with Ehlers-Danlos syndrome type III or hypermobility type (EDSIII). The association between FD and EDS III, and the underlying pathophysiological alterations, are poorly understood. We hypothesised that EDS III might influence gastroduodenal sensorimotor function, resulting in dyspeptic symptoms. Therefore, the aim of this study is to explore the impact of EDS III on gastric motility, nutrient tolerance and dyspeptic symptoms in patients with functional dyspepsia.Our aim is to study the prevalence of EDSIII in FD compared to healthy subjects (HS) and to study the impact of co-existing EDSIII on gastric motility, nutrient tolerance and dyspeptic symptoms in FD.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-04
• Primary Completion: 2016-11-01
• Study Completion: 2016-11-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients with PDS diagnosis as per Rome III by Rome III questionnaire

Exclusion Criteria

Patients are excluded from the study if any of the following criteria are met:

• Females who are pregnant or lactating.
• Patients who are H. Pylori positive
• Patients with confirmed gastro-intestinal disease, with former digestive surgery affecting upper gut motility, a concomitant disease responsible for digestive symptoms
• Patients presenting with predominant symptoms of irritable bowel syndrome (IBS), CIN or GERD.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric motility in JHS and non-JHS	2 years	This is a physiological parameter. Intragastric pressure measurement (mmHg) in JHS and non-JHS are compared to the Intragastric pressure measurement (mmHg) of healthy subjects. During the intragastric pressure measurement, the pressure drop (mmHg) from baseline during the intragastric infussion of a liquid meal will be assessed and compared in both groups (patients vs. controls).
Prevalence of JHS in functional dyspepsia	2 years	The number of patients with JHS and without JHS will be assessed. Based on the number of patients in each group, propotions (in %) can be calculated of the presence of JHS in a functional dyspepsia cohort.

Secondary Outcome Measures

Name	Time	Method
Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls	2 years	During the intragastric pressure assessment, a liquid nutrient drink is intragastrically infussed until the subjects experience and repport maximal satiation. Maximal satiation is assessed every minute during the intragastric infussion of the nutrient drink by means of questionnaires (VAS score: 0, no sensation; 5, maximal satiation). For this outcome, the quantity of nutrient drink tolerated during the test will be measured (ml) in patients with and without JHS and will be compared with the amount of volume (ml) assessed in healthy subjects.
Prevalence of dyspepsia symptoms	2 years	prevalence of dyspepsia symptoms in FD patients with JHS compared to patients without JHS.
Level of nutrient tolerance during the intragastric pressure measurement in JHS	2 years	During the intragastric pressure assessment, a liquid nutrient drink is intragastrically infussed until the subjects experience and repport maximal satiation. Maximal satiation is assessed every minute during the intragastric infussion of the nutrient drink by means of questionnaires (VAS score: 0, no sensation; 5, maximal satiation). For this outcome, the quantity of nutrient drink tolerated during the test will be measured (ml) in patients with and without JHS and compared.