Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Functional Dyspepsia Clinical Trial

Official title:

Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279990
• Other study ID #: S56804
• Status: Completed
• Start date: July 4, 2014
• Est. completion date: November 1, 2016

Study information

• Verified date: February 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Joint Hypermobility Syndrome
• Joint Instability
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Prevalence of dyspepsia symptoms	prevalence of dyspepsia symptoms in FD patients with JHS compared to patients without JHS.	2 years
Secondary	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
Secondary	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