Clinical trial NCT04279990: Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
Official title: Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Dyspepsia
Joint Hypermobility Syndrome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PDS diagnosis as per Rome III by Rome III questionnaire and healthy subjects with out gastrointestinal symptoms

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric motility in JHS and non-JHS
timeFrame: 2 years
measure: Prevalence of JHS in functional dyspepsia
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of dyspepsia symptoms
timeFrame: 2 years
measure: Level of nutrient tolerance during the intragastric pressure measurement in JHS
timeFrame: 2 years
measure: Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carbone F, Goelen N, Fikree A, Aziz Q, Tack J. Impact of joint hypermobility syndrome on gastric accommodation and nutrient tolerance in functional dyspepsia. Neurogastroenterol Motil. 2021 Jul;33(7):e14086. doi: 10.1111/nmo.14086. Epub 2021 Feb 2.