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

NCT04331223 | Completed

• 1 other identifier: DK5
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Gastrointestinal Disorders

Keywords

Irritable Bowel Syndrome; Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Association of clusters (primary outcome) with demographic patient characteristics.

  6 months

• Association of clusters (primary outcome) with gas concentrations during fructose and lactose breath test variables.

  6 months

• Association of clusters (primary outcome) with symptoms fructose and lactose breath test variables.

  6 months

Interventions

Observation OTHER

observational

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Male and female patients
• Have FGID at time of referral based on Rome III criteria
• Age over 18 years

You may not qualify if:

• Evidence of organic disease.
• Age below 18 years
• Documented refusal to allow data use

Sponsors & Collaborators

• Brain-Gut Research Group: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Gastoenterology Group Practice; Brain-Gut Research Group

Bern, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: April 2, 2020
• Study Start: December 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 31, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)