NCT04279990|Completed
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Sponsor study identifier
observational
54
0 countries
N/A
Study Start
July 4, 2014
Actual (reported)Primary Completion
November 1, 2016
Actual (reported)Study Completion
November 1, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 4, 2014
Actual (reported)November 1, 2016
Actual (reported)November 1, 2016
Actual (reported)February 11, 2020
Actual (reported)February 21, 2020
Actual (reported)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
Prevalence of dyspepsia symptoms
2 years
Level of nutrient tolerance during the intragastric pressure measurement in JHS
2 years
Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls
2 years
Patients with functional dyspepsia as defined by the Rome III criteria and joint hypermobility syndrome as defined by the Beighton Hypermobility criteria.
Patients with functional dyspepsia as defined by the Rome III criteria and WITHOUT joint hypermobility syndrome as defined by the Beighton Hypermobility criteria.
Healthy subjects with no gastrointestinal diseases including no functional dyspepsia
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.
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Patients with PDS diagnosis as per Rome III by Rome III questionnaire and healthy subjects with out gastrointestinal symptoms
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.
Jan Tack, MD
Universitaire Ziekenhuizen KU Leuven
54 participants (actual enrollment reported by the registry).
First Submitted
February 11, 2020
First Posted
February 21, 2020
Study Start
July 4, 2014
Actual (reported)The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2016
Actual (reported)Study Completion
November 1, 2016
Actual (reported)Last Updated
February 21, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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