The Association of Clinical Symptom Clusters With Underlying Mechanisms in Functional Gastrointestinal Disorders

Functional Gastrointestinal Disorders Clinical Trial

Official title:

The Association of Clinical Symptom Clusters With Underlying Mechanisms in Functional Gastrointestinal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331223
• Other study ID #: DK5
• Status: Completed
• Start date: December 15, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2020
• Source: Brain-Gut Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: August 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male and female patients

• Have FGID at time of referral based on Rome III criteria

• Age over 18 years

Exclusion Criteria:

• Evidence of organic disease.

• Age below 18 years

• Documented refusal to allow data use

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Syndrome

Intervention

Other:
• Observation
observational

Locations

Country	Name	City	State
Switzerland	Gastoenterology Group Practice; Brain-Gut Research Group	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Brain-Gut Research Group	Aalborg University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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').	6 months
Secondary	Association of clusters (primary outcome) with demographic patient characteristics.	Association of clinical symptom cluster(primary outcome) with demographic patient characteristics.	6 months
Secondary	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.	6 months
Secondary	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.	6 months