An observational study in Functional Gastrointestinal Disorders, sponsored by Brain-Gut Research Group. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by Brain-Gut Research Group · Observational
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.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
This study's enrollment of 5,000 is above the median of 350 across 147 observational studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Brain-Gut Research Group is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Male and female patients classified as having FGID at time of referral, based on Rome III criteria, and age over 18 years
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Exclusion Criteria:
observational
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').
Time frame: 6 months
Association of clusters (primary outcome) with demographic patient characteristics.
Association of clinical symptom cluster(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.
Testing of the association of clusters (primary outcome) with breath hydrogen, methane following fructose and lactose breath tests.
Time frame: 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.
Time frame: 6 months
Plan to share: No
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Ran from Dec 2018 to primary completion in Jun 2019, 6 months.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Brain-Gut Research Group