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

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 Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Gastoenterology Group Practice; Brain-Gut Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients classified as having FGID at time of referral, based on Rome III criteria, and age over 18 years

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of clusters (primary outcome) with demographic patient characteristics.	Association of clinical symptom cluster(primary outcome) with demographic patient characteristics.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Brain-Gut Research Group
• Collaborators: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Functional Dyspepsia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: DK5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No