Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

NCT04279990 | Completed

• 1 other identifier: S56804
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Dyspepsia; Joint Hypermobility Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

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

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

Healthy subjects

Healthy subjects with no gastrointestinal diseases including no functional dyspepsia

Other: No intervention: assessment of GI function

Interventions

No intervention: assessment of GI function OTHER

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.

Also known as: No intervention: assessment of JHS

Functional dyspepsia patients with JHS; Functional dyspepsia patients without JHS; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- Patients with PDS diagnosis as per Rome III by Rome III questionnaire

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• 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.

  PMID: 33528850 DERIVED

Study Officials

• Jan Tack, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 21, 2020
• Study Start: July 4, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 21, 2020

Record last verified: 2020-02