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Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

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ClinicalTrials.gov Identifier: NCT04279990
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment
Functional Dyspepsia Joint Hypermobility Syndrome Other: No intervention: assessment of GI function

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
Actual Study Start Date : July 4, 2014
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : November 1, 2016

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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 Name: 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 Name: 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 Name: No intervention: assessment of JHS




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Prevalence of dyspepsia symptoms [ Time Frame: 2 years ]
    prevalence of dyspepsia symptoms in FD patients with JHS compared to patients without JHS.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279990


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Jan Tack, MD Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04279990    
Other Study ID Numbers: S56804
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Instability
Syndrome
Dyspepsia
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Joint Diseases
Musculoskeletal Diseases