Functional Gastrointestinal DisordersNCT04331223
The Association of Clinical Symptom Clusters With Underlying Mechanisms in Functional Gastrointestinal Disorders
An observational study of Functional Gastrointestinal Disorders, run by Brain-Gut Research Group at 1 site in Switzerland.
Trial summary
Functional gastrointestinal disorders (FGID) are amongst the most common causes of abdominal pain and dysfunction seen in clinical practice, affecting between 10 to 15% of most populations (1). FGID are defined by symptoms without demonstrable underlying organic pathology (2). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Observation
- How many people
- 5,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2018to 31 Aug 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Male and female patients classified as having FGID at time of referral, based on Rome III criteria, and age over 18 years
Who may be able to join
- Male and female patients
- Have FGID at time of referral based on Rome III criteria
- Age over 18 years
Who cannot join
- Evidence of organic disease.
- Age below 18 years
- Documented refusal to allow data use
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Gastoenterology Group Practice; Brain-Gut Research Group
Bern
About this study
Functional gastrointestinal disorders (FGID) are amongst the most common causes of abdominal pain and dysfunction seen in clinical practice, affecting between 10 to 15% of most populations (1). FGID are defined by symptoms without demonstrable underlying organic pathology (2). Within the currently used Rome definitions of FGID, there is a broad range of gastrointestinal and multi-organ symptoms, indicating heterogeneous underlying pathophysiological mechanisms (3). There is evidence of central nervous system and motility dysfunction, dysbiosis, as well as immune activation in various subgroups of patients with FGID (2). Most mechanistic studies have been performed in small and heavily selected groups of patients. Consequently, the link between different symptomatic subgroups of patients and underlying mechanisms is unclear and unconfirmed in larger and representative patient cohorts. FGID patients with different underlying pathologies are likely to benefit from divergent specific treatments, even if they fall within the same Rome classification of FGID.
Discrete clusters of clinical characteristics in a large cohort of patients with FGID will be sought using hypothesis-free cluster analysis and latent-class analysis models. Associations to underlying mechanisms will be examined using data from fermentable sugar breath, blood and stool tests. This will allow recommendations regarding improved mechanistic-based classifications of patients with FGID, with potential for more effective mechanistic-based treatments.
The investigators will use coded clinical and medical history characteristics obtained by standardized questionnaires and laboratory and breath test results from all successive patients above the age of 18 years referred to the Gastroenterology Group Practice in the last 10 years for diagnosis and treatment of FGID for statistical analysis The data is stored in a database, without any personal identifiers. Explorative statistical analysis will be performed in approximately 5000 patients.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Observation
- Keywords
- Irritable Bowel Syndrome, Functional Dyspepsia
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Clusters of clinical symptoms in Rome III Functional GI disorders assessed by Likert scale and defined by latent class analysis.
Clusters defined by latent class modelling of the most commonly reported symptoms assessed by Likert scale (3-point numerical rating scale ranging from 'none' to 'severe').
Measured: 6 months
Secondary outcomes (3)
Association of clusters (primary outcome) with demographic patient characteristics.
Association of clinical symptom cluster(primary outcome) with demographic patient characteristics.
Measured: 6 months
Association of clusters (primary outcome) with gas concentrations during fructose and lactose breath test variables.
Testing of the association of clusters (primary outcome) with breath hydrogen, methane following fructose and lactose breath tests.
Measured: 6 months
Association of clusters (primary outcome) with symptoms fructose and lactose breath test variables.
Testing of the association of clusters (primary outcome) with symptoms rated by Likert scale (3-point numerical rating scale ranging from 'none' to 'severe') following fructose and lactose breath tests.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start15 Dec 2018
- Primary completion30 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain-Gut Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331223
- Sponsor's protocol ID
- DK5
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2018
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Clinical Symptom Clusters With Underlying Mechanisms in Functional Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT04331223
- Acronym / sponsor ID
- DK5
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Irritable Bowel Syndrome, Functional Dyspepsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Brain-Gut Research GroupUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 2 Apr 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 gastrointestinal disorders (FGID) are amongst the most common causes of abdominal pain and dysfunction seen in clinical practice, affecting between 10 to 15% of most populations (1). FGID are defined by symptoms without demonstrable underlying organic pathology (2). Within the currently used Rome definitions of FGID, there is a broad range of gastrointestinal and multi-organ symptoms, indicating heterogeneous underlying pathophysiological mechanisms (3). There is evidence of central nervous system and motility dysfunction, dysbiosis, as well as immune activation in various subgroups of patients with FGID (2). Most mechanistic studies have been performed in small and heavily selected groups of patients. Consequently, the link between different symptomatic subgroups of patients and underlying mechanisms is unclear and unconfirmed in larger and representative patient cohorts. FGID patients with different underlying pathologies are likely to benefit from divergent specific treatments, even if they fall within the same Rome classification of FGID.
Discrete clusters of clinical characteristics in a large cohort of patients with FGID will be sought using hypothesis-free cluster analysis and latent-class analysis models. Associations to underlying mechanisms will be examined using data from fermentable sugar breath, blood and stool tests. This will allow recommendations regarding improved mechanistic-based classifications of patients with FGID, with potential for more effective mechanistic-based treatments.
The investigators will use coded clinical and medical history characteristics obtained by standardized questionnaires and laboratory and breath test results from all successive patients above the age of 18 years referred to the Gastroenterology Group Practice in the last 10 years for diagnosis and treatment of FGID for statistical analysis The data is stored in a database, without any personal identifiers. Explorative statistical analysis will be performed in approximately 5000 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male and female patients classified as having FGID at time of referral, based on Rome III criteria, and age over 18 years
Key inclusion criteria (3 listed)
- Male and female patients
- Have FGID at time of referral based on Rome III criteria
- Age over 18 years
Key exclusion criteria (3 listed)
- Evidence of organic disease.
- Age below 18 years
- Documented refusal to allow data use
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 |
|---|---|---|
| Observationobservational | Other | – |
Primary outcome
Clusters of clinical symptoms in Rome III Functional GI disorders assessed by Likert scale and defined by latent class analysis.
Time frame: 6 months
Clusters defined by latent class modelling of the most commonly reported symptoms assessed by Likert scale (3-point numerical rating scale ranging from 'none' to 'severe').
3 secondary outcomes
Association of clusters (primary outcome) with demographic patient characteristics.
Time frame: 6 months
Association of clusters (primary outcome) with gas concentrations during fructose and lactose breath test variables.
Time frame: 6 months
Association of clusters (primary outcome) with symptoms fructose and lactose breath test variables.
Time frame: 6 months
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 2 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders, run by Brain-Gut Research Group at 1 site in Switzerland.
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 3 inclusion and 3 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clusters of clinical symptoms in Rome III Functional GI disorders assessed by Likert scale and defined by latent class analysis. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2020.