Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2016

Interventions

  • Other: No intervention: assessment of GI function
    • 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.

Arms, Groups and Cohorts

  • Functional dyspepsia patients with JHS
    • Patients with functional dyspepsia as defined by the Rome III criteria and joint hypermobility syndrome as defined by the Beighton Hypermobility criteria.
  • Functional dyspepsia patients without JHS
    • Patients with functional dyspepsia as defined by the Rome III criteria and WITHOUT joint hypermobility syndrome as defined by the Beighton Hypermobility criteria.
  • Healthy subjects
    • Healthy subjects with no gastrointestinal diseases including no functional dyspepsia

Clinical Trial Outcome Measures

Primary Measures

  • Gastric motility in JHS and non-JHS
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Prevalence of dyspepsia symptoms
    • Time Frame: 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
    • Time Frame: 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.
  • Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Tack, MD, Principal Investigator, Universitaire Ziekenhuizen KU Leuven

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