Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

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 Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Joint Hypermobility Syndrome
• Intervention / Treatment: Other: No intervention: assessment of GI function

• Study Type: Observational
• Enrollment (Actual): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: No intervention: assessment of JHS
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.	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.; Other Names: No intervention: assessment of JHS
Healthy subjects; Healthy subjects with no gastrointestinal diseases including no functional dyspepsia	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.; Other Names: No intervention: assessment of JHS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2014
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (ACTUAL): February 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Joint Diseases; Musculoskeletal Diseases; Syndrome; Dyspepsia; Joint Instability
• Other Study ID Numbers: S56804

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No