Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 54
- Primary Endpoint
- Gastric motility in JHS and non-JHS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
- Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls(2 years)
- Prevalence of dyspepsia symptoms(2 years)
- Level of nutrient tolerance during the intragastric pressure measurement in JHS(2 years)