Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

NCT ID: NCT04279990

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-04
• Study Completion Date: 2016-11-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No intervention: assessment of GI function

Intervention Type: 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.

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.

No intervention: assessment of GI function

Intervention Type: 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.

Healthy subjects

Healthy subjects with no gastrointestinal diseases including no functional dyspepsia

No intervention: assessment of GI function

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

No intervention: assessment of JHS

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tack, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

References

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.

Reference Type: DERIVED

PMID: 33528850 (View on PubMed)

Other Identifiers

S56804

Identifier Type: -

Identifier Source: org_study_id