Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Conditions
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Functional Dyspepsia, Joint Hypermobility Syndrome

Intervention / Treatment
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* Other: No intervention: assessment of GI function


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Functional dyspepsia patients with JHS<br>Patients with functional dyspepsia as defined by the Rome III criteria and joint hypermobility syndrome as defined by the Beighton Hypermobility criteria. | Other: No intervention: assessment of GI function<br>* Gastrointestinal function is assessed by the intragastric pressure measurement by a high resolution manometry. This is an examination test considered standard of care for the diagnosis of functional dyspepsia in the university hospital of leuven. The joint hypermobility syndrome is assess by means of the Brighton criteria.<br>* Other names: No intervention: assessment of JHS;|
| Functional dyspepsia patients without JHS<br>Patients with functional dyspepsia as defined by the Rome III criteria and WITHOUT joint hypermobility syndrome as defined by the Beighton Hypermobility criteria. | Other: No intervention: assessment of GI function<br>* Gastrointestinal function is assessed by the intragastric pressure measurement by a high resolution manometry. This is an examination test considered standard of care for the diagnosis of functional dyspepsia in the university hospital of leuven. The joint hypermobility syndrome is assess by means of the Brighton criteria.<br>* Other names: No intervention: assessment of JHS;|
| Healthy subjects<br>Healthy subjects with no gastrointestinal diseases including no functional dyspepsia | Other: No intervention: assessment of GI function<br>* Gastrointestinal function is assessed by the intragastric pressure measurement by a high resolution manometry. This is an examination test considered standard of care for the diagnosis of functional dyspepsia in the university hospital of leuven. The joint hypermobility syndrome is assess by means of the Brighton criteria.<br>* Other names: No intervention: assessment of JHS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric motility in JHS and non-JHS | 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). | 2 years | 
| Prevalence of JHS in functional dyspepsia | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dyspepsia symptoms | prevalence of dyspepsia symptoms in FD patients with JHS compared to patients without JHS. | 2 years | 
| Level of nutrient tolerance during the intragastric pressure measurement in JHS | 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. | 2 years | 
| Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls | 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. | 2 years |