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OpenTrials
Completed

NCT Number: NCT04331223

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastoenterology Group Practice; Brain-Gut Research Group

Bern, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

observational

Primary outcomes

  1. 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').

Secondary outcomes

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

    Time frame: 6 months

    Association of clinical symptom cluster(primary outcome) with demographic patient characteristics.

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

    Time frame: 6 months

    Testing of the association of clusters (primary outcome) with breath hydrogen, methane following fructose and lactose breath tests.

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

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Brain-Gut Research Group

Other

Collaborators

  • Aalborg University Hospital

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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