Functional DyspepsiaNCT04279990
Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
An observational study of Functional Dyspepsia and Joint Hypermobility Syndrome, run by Universitaire Ziekenhuizen KU Leuven.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Joint Hypermobility Syndrome
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2014to 1 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with PDS diagnosis as per Rome III by Rome III questionnaire and healthy subjects with out gastrointestinal symptoms
Who may be able to join
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire
Who cannot join
- 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.
About this study
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
- Being tested
- No intervention: assessment of GI function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention: assessment of GI functionOther
Also called No intervention: assessment of JHS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention: assessment of GI function | |
| Healthy subjects | Healthy subjects with no gastrointestinal diseases including no functional dyspepsia Receives: Other: No intervention: assessment of GI function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2 years
Secondary outcomes (3)
Prevalence of dyspepsia symptoms
prevalence of dyspepsia symptoms in FD patients with JHS compared to patients without JHS.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start4 Jul 2014
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279990
- Sponsor's protocol ID
- S56804
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33528850
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome
- ClinicalTrials.gov ID
- NCT04279990
- Acronym / sponsor ID
- S56804
- Conditions
- Functional Dyspepsia, Joint Hypermobility Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 4 Jul 2014 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia patients with JHS | – | Other: No intervention: assessment of GI functionPatients with functional dyspepsia as defined by the Rome III criteria and joint hypermobility syndrome as defined by the Beighton Hypermobility criteria. |
| Functional dyspepsia patients without JHS | – | Other: No intervention: assessment of GI functionPatients with functional dyspepsia as defined by the Rome III criteria and WITHOUT joint hypermobility syndrome as defined by the Beighton Hypermobility criteria. |
| Healthy subjects | – | Other: No intervention: assessment of GI functionHealthy subjects with no gastrointestinal diseases including no functional dyspepsia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire and healthy subjects with out gastrointestinal symptoms
Key inclusion criteria (1 listed)
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention: assessment of GI functionAlso: No intervention: assessment of JHSGastrointestinal 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 | Functional dyspepsia patients with JHS, Functional dyspepsia patients without JHS, Healthy subjects |
Primary outcome
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).
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.
3 secondary outcomes
Prevalence of dyspepsia symptoms
Time frame: 2 years
Level of nutrient tolerance during the intragastric pressure measurement in JHS
Time frame: 2 years
Level of nutrient tolerance during the intragastric pressure measurement in patients vs controls
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 33528850Carbone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia and Joint Hypermobility Syndrome, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric motility in JHS and non-JHS (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.