To provide an extensive clinical and psychosocial characterization of IBS patients with and without psychological and/or physical comorbidities, as well as of disease-controls without IBS, but with psychological and/or physical disease, and a…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Muscle disorders
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study outcomes are divided into clinical characteristics (symptom scores for GI
symptoms, other somatic symptoms, fatigue, psychological symptoms, nutrition,
physical activity, and sleep pattern) and biological parameters (measurements
from blood samples, fecal samples, colon biopsies, and a multi-sugar
permeability test, and two stress assessments targeted at different
pathophysiological mechanisms).
Primary study parameters are symptom scores from questionnaires:
- GI symptoms: IBS-SSS.
- Somatic symptoms other than GI symptoms: PHQ-15.
- Symptoms and severity of fibromyalgia: FIQ.
- Psychological symptoms: GAD-7, PHQ-9.
- Presence and severity of fatigue: MFI.
- Nutritional pattern: FFQ.
Secondary outcome
Symptom scores according to momentary assessment using ESM:
- GI symptoms
- Psychological symptoms
Environmental, social, and behavioral features according to momentary
assessment using ESM.
Lifestyle factors registered by the humanITcare platform: physical activity,
heart rate, sleep pattern.
Previous traumatic exposure: BTQ.
Parameters from biomaterials:
- Paracellular in vivo passage of large molecules (i.e. endotoxins, bacterial
products): blood samples.
- GI permeability studies by multiple sugar test.
- Gut microbiota, including bacterial cell counting, metabolomic,
transcriptomic and metagenomic analyses, cultivation of micro-organisms: fecal
samplen, colon biopsies
- Dry weight percentage as an objective measure of stool consistency: fecal
samples.
- Calprotectin as a measure of (low grade) inflammation: fecal samples.
- Whole genome SNP detection as a measure of genetic variants for phenotype
association studies: blood samples.
- Molecular, cellular, and ultrastructural characterization of the intestinal
mucosa, with a specific focus on intestinal barrier function, immune mucosal
cell populations and enteric nerve fibers involved in neuro-plastic changes,
eosinophil and mast cell degranulation, cell-to-cell interaction, including
association between immunocytes, the epithelium and nerve fibers, and molecular
transcriptome/proteome profiling: colonic biopsies.
- Resting state functional connectivity, regional cerebral blood flow with
blood oxygen-dependent level (BOLD) and arterial spin labeling (ASL): fMRI scan
during MIST.
- Neural responses to psychosocial stress: fMRI scan during MIST.
- Subjective and cortisol responses to stress: during MAST.
Background summary
The etiology and pathophysiology of IBS are incompletely understood, which
hampers adequate diagnosis, follow-up of disease course over time, evaluation
of therapy efficacy, and the development of new effective treatments. This
leads to reduced quality of life for affected individuals and, together with a
high world-wide prevalence, an important burden on health care as well as high
costs for society. Better understanding of IBS etiology and pathophysiology,
and its relation to common comorbid psychological and physical disorders, is
necessary in order to clear the way to novel (personalized) effective treatment
options.
Study objective
To provide an extensive clinical and psychosocial characterization of IBS
patients with and without psychological and/or physical comorbidities, as well
as of disease-controls without IBS, but with psychological and/or physical
disease, and a healthy control group without IBS and comorbid
psychological/physical disease. This will form a basis for the evaluation of
similarities and/or differences in underlying pathophysiology and clinical
characteristics between the different groups in order to better understand IBS
and its comorbidities in the context of pathophysiology, disease course, and
treatment efficacy of currently available treatment options.
Study design
This project concerns a European multi-center prospective, longitudinal,
case-control observational study with a total duration of 4 years, including
measurements at baseline, after 1 year, and after 2 years.
Study burden and risks
This study does not involve any incapacitated or minority groups, and is
considered a low-risk study. No treatments or investigational products are
involved. The obligatory part of the study consists of completing digital
questionnaires (at home), which will take about 0.5 hours, in addition to two
visits to Maastricht University. In case subjects agree to also participate in
additional assessments, the second visit will take somewhat longer, and
subjects need to perform the additional measurements (depending on which
assessments they decide to undergo). These include collecting blood and fecal
samples, performing a multi-sugar permeability test by collecting 24-hour urine
after ingestion of a multi-sugar drink, collecting data via an eHealth
platform, and completing digital questionnaires using ESM (and collecting
colonic biopsies during a colonoscopy already requested by their treating
physician as part of clinical care). Participants will be asked to also perform
similar assessments after 1 and 2 years of follow-up. Apart from these clinical
assessment visits, two optional stress function assessment visits can be
scheduled to assess brain function and neuroendocrine stress system function.
No important health risks are considered. Subjects will not directly benefit
from participation in this study.
UNS 50
Maastricht 6229ER
NL
UNS 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of IBS according to Rome IV criteria
- Aged 18 years or older
- Ability to understand written Dutch and speak the Dutch language
Exclusion criteria
- Any organic explanation for the abdominal complaints.
- A history of abdominal surgery, except for uncomplicated appendectomy,
laparoscopic cholecystectomy, and hysterectomy.
- Participation in another clinical study interfering with study activities or
study objectives of this study, 1 month prior to the screening visit and
throughout the study.
- Other severe disease(s) such as malignancy, severe heart disease, kidney
disease or neurological disease, interfering with study evaluations.
- Severe psychiatric disease, other than the comorbid conditions explicitly
studied, with necessary additional psychopharmacotherapy or psychiatric
intervention involving day-care/ inpatient treatment at start of study or
during the study, especially a diagnosis of bipolar disorder, schizophrenia,
autism spectrum disorder, schizoaffective disorder or organic psychiatric
disorder (current OR lifetime).
- Previous history of drug or alcohol abuse 6 months prior to screening.
- Consumption of antibiotics 3 months prior to the baseline visit.
- Pregnant or lactating at the baseline visit.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75159.068.20 |